Trial Outcomes & Findings for Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED) (NCT NCT00350623)
NCT ID: NCT00350623
Last Updated: 2015-08-25
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
210 participants
Primary outcome timeframe
30 weeks
Results posted on
2015-08-25
Participant Flow
Phase IIa; First Patient In: 24-Oct-2006; Last Patient Last Visit 30-May-2008. 21 sites, all in the United States of America.
All patients had to demonstrate good health, be at low risk of acquiring HIV infection, and met a number of laboratory criteria. They could not have previously received an investigational HIV vaccine, had a contraindication to intramuscular injection, or weighed less than 105 pounds.
Participant milestones
| Measure |
MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose
MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose
MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10\^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
|---|---|---|---|
|
Overall Study
STARTED
|
71
|
71
|
68
|
|
Overall Study
COMPLETED
|
63
|
67
|
62
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
6
|
Reasons for withdrawal
| Measure |
MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose
MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose
MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10\^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
patient traveling outside the country
|
0
|
0
|
1
|
Baseline Characteristics
Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)
Baseline characteristics by cohort
| Measure |
MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose
n=71 Participants
MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose
n=71 Participants
MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose
n=68 Participants
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10\^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30.6 years
n=99 Participants
|
31.5 years
n=107 Participants
|
32.0 years
n=206 Participants
|
31.4 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
106 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
104 Participants
n=7 Participants
|
|
Ethnicity
Hispanic or Latino
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
62 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
180 Participants
n=7 Participants
|
|
Race
Asian
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Race
Black or African American
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
10 participants
n=206 Participants
|
28 participants
n=7 Participants
|
|
Race
Multi-Racial
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
1 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Race
Other (Unknown)
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Race
White
|
57 participants
n=99 Participants
|
57 participants
n=107 Participants
|
52 participants
n=206 Participants
|
166 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 30 weeksPopulation: No data analysis was performed.
Outcome measures
Outcome data not reported
Adverse Events
MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose
Serious events: 0 serious events
Other events: 63 other events
Deaths: 0 deaths
MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose
Serious events: 2 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose
n=71 participants at risk
MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose
n=71 participants at risk
MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose
n=68 participants at risk
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10\^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
1.5%
1/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
1.5%
1/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
Other adverse events
| Measure |
MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose
n=71 participants at risk
MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose
n=71 participants at risk
MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose
n=68 participants at risk
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10\^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
|
|---|---|---|---|
|
Eye disorders
Eye pruritus
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
0.00%
0/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Eye disorders
Photophobia
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
2.9%
2/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
0.00%
0/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
3/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
7.0%
5/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
7.4%
5/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
4/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
12.7%
9/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
7.4%
5/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
1.4%
1/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
2.9%
2/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
General disorders
Chills
|
4.2%
3/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
5.6%
4/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
14.7%
10/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
General disorders
Fatigue
|
5.6%
4/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
7.0%
5/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
16.2%
11/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
General disorders
Hangover
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
4.4%
3/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
General disorders
Influenza like illness
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
5.6%
4/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
2.9%
2/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
General disorders
Injection site bruising
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
4.4%
3/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
General disorders
Injection site erythema
|
22.5%
16/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
29.6%
21/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
19.1%
13/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
General disorders
Injection site movement impairment
|
1.4%
1/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
0.00%
0/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
General disorders
Injection site pain
|
62.0%
44/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
76.1%
54/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
69.1%
47/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
General disorders
Injection site pruritus
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
5.6%
4/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
1.5%
1/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
General disorders
Injection site swelling
|
16.9%
12/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
28.2%
20/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
22.1%
15/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
General disorders
Malaise
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
7.0%
5/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
7.4%
5/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
General disorders
Pain
|
1.4%
1/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
8.5%
6/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
10.3%
7/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
General disorders
Pyrexia
|
4.2%
3/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
12.7%
9/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
19.1%
13/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Infections and infestations
Pharyngitis
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
1.4%
1/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
1.5%
1/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
1/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
4.2%
3/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
11.8%
8/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
3/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
1.4%
1/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
2.9%
2/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
4.2%
3/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
1.5%
1/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.9%
7/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
4.2%
3/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
11.8%
8/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
1.4%
1/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
2.9%
2/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Nervous system disorders
Dizziness
|
4.2%
3/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
5.6%
4/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
7.4%
5/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Nervous system disorders
Headache
|
19.7%
14/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
43.7%
31/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
30.9%
21/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
2.9%
2/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Psychiatric disorders
Insomnia
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
1.5%
1/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
7.0%
5/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
0.00%
0/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
4.2%
3/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
2.9%
2/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.4%
1/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
5.6%
4/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
5.9%
4/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.0%
5/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
9.9%
7/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
10.3%
7/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
2.8%
2/71 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
0.00%
0/68 • Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER