Trial Outcomes & Findings for To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination (NCT NCT00353366)
NCT ID: NCT00353366
Last Updated: 2021-03-16
Results Overview
Grade 2 or 3 symptoms assessed include fever, vomiting and diarrhea. Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C or rectal temperature above 38.5°C and below or equal to 39.5°C. Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhea was defined as at least 6 looser than normal stools per day.
Recruitment status
COMPLETED
Target enrollment
1439 participants
Primary outcome timeframe
During the 15-day (Days 0-14) solicited follow-up period after each vaccine dose (Dose 1 and Dose 2).
Results posted on
2021-03-16
Participant Flow
Participant milestones
| Measure |
Rotarix Group
Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.
|
|---|---|
|
Overall Study
STARTED
|
1439
|
|
Overall Study
COMPLETED
|
1296
|
|
Overall Study
NOT COMPLETED
|
143
|
Reasons for withdrawal
| Measure |
Rotarix Group
Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Protocol Violation
|
12
|
|
Overall Study
Withdrawal by Subject
|
12
|
|
Overall Study
Lost to Follow-up
|
92
|
|
Overall Study
Other
|
19
|
Baseline Characteristics
To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
Baseline characteristics by cohort
| Measure |
Rotarix Group
n=1439 Participants
Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.
|
|---|---|
|
Age, Continuous
|
11.2 Weeks
STANDARD_DEVIATION 3.88 • n=99 Participants
|
|
Sex: Female, Male
Female
|
692 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
747 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: During the 15-day (Days 0-14) solicited follow-up period after each vaccine dose (Dose 1 and Dose 2).Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.
Grade 2 or 3 symptoms assessed include fever, vomiting and diarrhea. Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C or rectal temperature above 38.5°C and below or equal to 39.5°C. Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhea was defined as at least 6 looser than normal stools per day.
Outcome measures
| Measure |
Rotarix Group
n=1439 Participants
Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.
|
|---|---|
|
Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea).
Grade 2/3;Dose 1
|
147 Subjects
|
|
Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea).
Grade 2/3; Dose 2
|
98 Subjects
|
|
Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea).
Grade 2/3; Across Doses
|
212 Subjects
|
SECONDARY outcome
Timeframe: During the 15-day solicited follow-up period (Day 0 to Day 14) after each vaccine dose (Dose 1 and Dose 2).Population: The analysis was performed on the Total Vaccinated cohort , which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.
Solicited symptoms assessed included cough, diarrhea, fever, irritability, loss of appetite and vomiting. Any = Any reports of the specified symptom irrespective of intensity grade and relationship to vaccination. Grade 3 symptom: symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all, grade 3 fever = axillary temperature \> 39.0°C, grade 3 vomiting = ≥ 3 episodes of vomiting/day and grade 3 diarrhea = ≥ 6 looser than normal stools/day. Related = symptom assessed by the investigator as causally related to the vaccination regardless of intensity grade.
Outcome measures
| Measure |
Rotarix Group
n=1439 Participants
Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.
|
|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Cough; Dose 1
|
311 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Cough; Dose 1
|
13 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Cough; Dose 1
|
15 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Diarrhea; Dose 1
|
69 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Diarrhea; Dose 1
|
13 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Diarrhea; Dose 1
|
26 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature; Dose 1
|
130 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Temperature; Dose 1
|
3 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature; Dose 1
|
26 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Irritability; Dose 1
|
464 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Irritability; Dose 1
|
36 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Irritability; Dose 1
|
100 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Loss of appetite; Dose 1
|
269 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Loss of appetite; Dose 1
|
4 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Loss of appetite; Dose 1
|
74 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Vomiting; Dose 1
|
190 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Vomiting; Dose 1
|
44 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Vomiting; Dose 1
|
38 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Cough; Dose 2
|
256 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Cough; Dose 2
|
7 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Cough; Dose 2
|
27 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Diarrhea; Dose 2
|
38 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Diarrhea; Dose 2
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Diarrhea; Dose 2
|
14 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature; Dose 2
|
130 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Temperature; Dose 2
|
4 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature; Dose 2
|
24 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Irritability; Dose 2
|
307 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Irritability; Dose 2
|
24 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Irritability; Dose 2
|
71 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Loss of appetite; Dose 2
|
193 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Loss of appetite; Dose 2
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Loss of appetite; Dose 2
|
43 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Vomiting; Dose 2
|
113 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Vomiting; Dose 2
|
13 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Vomiting; Dose 2
|
22 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Cough; Across Doses
|
443 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Cough; Across Doses
|
18 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Cough; Across Doses
|
39 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Diarrhea; Across Doses
|
93 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Diarrhea; Across Doses
|
18 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Diarrhea; Across Doses
|
36 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature; Across Doses
|
226 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Temperature; Across Doses
|
7 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature; Across Doses
|
48 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Irritability; Across Doses
|
545 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Irritability; Across Doses
|
51 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Irritability; Across Doses
|
130 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Loss of appetite; Across Doses
|
351 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Loss of appetite; Across Doses
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Loss of appetite; Across Doses
|
93 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Vomiting; Across Doses
|
240 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Vomiting; Across Doses
|
54 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Vomiting; Across Doses
|
49 Subjects
|
SECONDARY outcome
Timeframe: During the 31-day follow-up period (Day 0 to Day 30) after any vaccine dose.Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Outcome measures
| Measure |
Rotarix Group
n=1439 Participants
Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.
|
|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AE)
|
352 Subjects
|
SECONDARY outcome
Timeframe: Throughout the study period (Day 0 to one month post-Dose 2).Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Rotarix Group
n=1439 Participants
Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.
|
|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
|
33 Participants
|
Adverse Events
Rotarix Group
Serious events: 33 serious events
Other events: 827 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rotarix Group
n=1439 participants at risk
Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.
|
|---|---|
|
Infections and infestations
Bronchopneumonia
|
0.56%
8/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Infections and infestations
Urinary tract infection
|
0.35%
5/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Infections and infestations
Amoebic dysentery
|
0.28%
4/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Infections and infestations
Pneumonia
|
0.28%
4/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Infections and infestations
Amoebiasis
|
0.14%
2/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Infections and infestations
Bronchiolitis
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Infections and infestations
Bronchitis
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Gastrointestinal disorders
Constipation
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Infections and infestations
Diarrhoea infections
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Skin and subcutaneous tissue disorders
Exanthema subitum
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Infections and infestations
Gastroenteritis
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Nervous system disorders
Hypersomnia
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Nervous system disorders
Hypophagia
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Gastrointestinal disorders
Intussusception
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Immune system disorders
Milk anyergy
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Infections and infestations
Pneumonia bacterial
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Infections and infestations
Roseola
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Infections and infestations
Viral rash
|
0.07%
1/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
Other adverse events
| Measure |
Rotarix Group
n=1439 participants at risk
Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.
|
|---|---|
|
General disorders
Cough
|
30.8%
443/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
93/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
General disorders
Fever
|
15.7%
226/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
General disorders
Irritability
|
37.9%
545/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
General disorders
Loss of appetite
|
24.4%
351/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
|
General disorders
Vomiting
|
16.7%
240/1439 • Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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