Trial Outcomes & Findings for Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study) (NCT NCT04978818)
NCT ID: NCT04978818
Last Updated: 2024-06-24
Results Overview
The non-inferiority of the anti-PRP IgG Geometric Mean Concentration (GMC) 30 days after dose 1 of Vaxelis administered at 2 months of age, compared to PedvaxHIB. GMC was modeled using constrained longitudinal analysis (cLDA) of anti-PRP IgG concentration at all study visits.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
333 participants
Primary outcome timeframe
30 days after dose 1
Results posted on
2024-06-24
Participant Flow
American Indian and Alaska Native (AI/AN) infants receiving primary care at five Indian Health Service (IHS)/Tribal Health facilities in Alaska and the Navajo Nation were recruited from December 2021 to April 2023. The first participant was enrolled in January 2022.
1736 infants were screened for eligibility and 333 infants were enrolled in the study.
Participant milestones
| Measure |
PedvaxHIB Arm
166 infants will be randomized to the PedvaxHIB group, which is licensed for primary vaccination at 2 and 4 months of age.
PedvaxHIB: Eligible infants will be block randomized to one of two study arms.
|
Vaxelis
167 infants will be randomized to the Vaxelis group, which is licensed for primary vaccination at 2, 4 and 6 months of age.
Vaxelis: Eligible infants will be block randomized to one of two study arms.
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
167
|
|
Overall Study
COMPLETED
|
144
|
152
|
|
Overall Study
NOT COMPLETED
|
22
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study)
Baseline characteristics by cohort
| Measure |
PedvaxHIB Arm
n=166 Participants
Participants received 0.5 mL doses of PedvaxHIB® (7.5 µg/mL PRP-OMP) administered intramuscularly at age 2 months and 4 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
Vaxelis
n=167 Participants
Participants received 0.5 mL doses of Vaxelis® (3.0 µg/mL PRP-OMP + diphtheria, tetanus, pertussis \[acellular, component\], poliomyelitis \[inactivated\], and hepatitis B \[recombinant deoxyribonucleic acid (rDNA)) administered intramuscularly at age 2 months, 4 months and 6 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 Days
n=99 Participants
|
60 Days
n=107 Participants
|
60 Days
n=206 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
175 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
166 Participants
n=99 Participants
|
167 Participants
n=107 Participants
|
333 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 days after dose 1Population: All specimens were included for which valid concentration results were obtained adhering to study procedures and intervals between primary doses, as defined in the protocol. Participants with incomplete data for the time series contribute their available data to the overall model.
The non-inferiority of the anti-PRP IgG Geometric Mean Concentration (GMC) 30 days after dose 1 of Vaxelis administered at 2 months of age, compared to PedvaxHIB. GMC was modeled using constrained longitudinal analysis (cLDA) of anti-PRP IgG concentration at all study visits.
Outcome measures
| Measure |
PedvaxHIB Arm
n=163 Participants
Participants received 0.5 mL doses of PedvaxHIB® (7.5 µg/mL PRP-OMP) administered intramuscularly at age 2 months and 4 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
Vaxelis
n=167 Participants
Participants received 0.5 mL doses of Vaxelis® (3.0 µg/mL PRP-OMP + diphtheria, tetanus, pertussis \[acellular, component\], poliomyelitis \[inactivated\], and hepatitis B \[recombinant deoxyribonucleic acid (rDNA)) administered intramuscularly at age 2 months, 4 months and 6 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
|---|---|---|
|
Anti-PRP IgG Geometric Mean Concentration (GMC)
|
0.40 μg/mL
Interval 0.31 to 0.5
|
0.41 μg/mL
Interval 0.33 to 0.51
|
SECONDARY outcome
Timeframe: 30 days after dose 1 of Vaxelis or PedvaxHIBPopulation: All specimens from which valid concentration measurements were made from participants adhering to study procedures and intervals between primary doses, as defined in the protocol.
Describe the percent of infants with anti-PRP IgG ≥0.15 µg/mL 30 days after dose 1 of Vaxelis or PedvaxHIB.
Outcome measures
| Measure |
PedvaxHIB Arm
n=146 Participants
Participants received 0.5 mL doses of PedvaxHIB® (7.5 µg/mL PRP-OMP) administered intramuscularly at age 2 months and 4 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
Vaxelis
n=152 Participants
Participants received 0.5 mL doses of Vaxelis® (3.0 µg/mL PRP-OMP + diphtheria, tetanus, pertussis \[acellular, component\], poliomyelitis \[inactivated\], and hepatitis B \[recombinant deoxyribonucleic acid (rDNA)) administered intramuscularly at age 2 months, 4 months and 6 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
|---|---|---|
|
Percent of Anti-PRP IgG ≥0.15 µg/mL 30 Days After Dose 1
|
104 Participants
|
115 Participants
|
SECONDARY outcome
Timeframe: 30 days after dose 1 of Vaxelis or PedvaxHIBPopulation: All specimens from which valid concentration measurements were made from participants adhering to study procedures and intervals between primary doses, as defined in the protocol.
Describe the percent of infants with anti-PRP IgG ≥1.0 µg/mL 30 days after dose 1 of Vaxelis or PedvaxHIB.
Outcome measures
| Measure |
PedvaxHIB Arm
n=146 Participants
Participants received 0.5 mL doses of PedvaxHIB® (7.5 µg/mL PRP-OMP) administered intramuscularly at age 2 months and 4 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
Vaxelis
n=152 Participants
Participants received 0.5 mL doses of Vaxelis® (3.0 µg/mL PRP-OMP + diphtheria, tetanus, pertussis \[acellular, component\], poliomyelitis \[inactivated\], and hepatitis B \[recombinant deoxyribonucleic acid (rDNA)) administered intramuscularly at age 2 months, 4 months and 6 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
|---|---|---|
|
Percent of Anti-PRP IgG ≥1.0 µg/mL 30 Days After Dose 1
|
40 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIBPopulation: All specimens from which valid concentration measurements were made from participants adhering to study procedures and intervals between primary doses, as defined in the protocol.
Describe the percent of infants with anti-PRP IgG ≥0.15 µg/mL on Day 121 after initiation of the primary series, i.e., 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB.
Outcome measures
| Measure |
PedvaxHIB Arm
n=122 Participants
Participants received 0.5 mL doses of PedvaxHIB® (7.5 µg/mL PRP-OMP) administered intramuscularly at age 2 months and 4 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
Vaxelis
n=133 Participants
Participants received 0.5 mL doses of Vaxelis® (3.0 µg/mL PRP-OMP + diphtheria, tetanus, pertussis \[acellular, component\], poliomyelitis \[inactivated\], and hepatitis B \[recombinant deoxyribonucleic acid (rDNA)) administered intramuscularly at age 2 months, 4 months and 6 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
|---|---|---|
|
Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 121
|
115 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIBPopulation: All specimens from which valid concentration measurements were made from participants adhering to study procedures and intervals between primary doses, as defined in the protocol.
Describe the percent of infants with anti-PRP IgG ≥1.0 µg/mL on Day 121 after initiation of the primary series, i.e., 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB.
Outcome measures
| Measure |
PedvaxHIB Arm
n=122 Participants
Participants received 0.5 mL doses of PedvaxHIB® (7.5 µg/mL PRP-OMP) administered intramuscularly at age 2 months and 4 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
Vaxelis
n=133 Participants
Participants received 0.5 mL doses of Vaxelis® (3.0 µg/mL PRP-OMP + diphtheria, tetanus, pertussis \[acellular, component\], poliomyelitis \[inactivated\], and hepatitis B \[recombinant deoxyribonucleic acid (rDNA)) administered intramuscularly at age 2 months, 4 months and 6 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
|---|---|---|
|
Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 121
|
100 Participants
|
102 Participants
|
SECONDARY outcome
Timeframe: 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIBPopulation: All specimens from which valid concentration measurements were made from participants adhering to study procedures and intervals between primary doses, as defined in the protocol.
Describe the percent of infants with anti-PRP IgG ≥0.15 µg/mL on Day 151 after initiation of the primary series, i.e., 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB.
Outcome measures
| Measure |
PedvaxHIB Arm
n=117 Participants
Participants received 0.5 mL doses of PedvaxHIB® (7.5 µg/mL PRP-OMP) administered intramuscularly at age 2 months and 4 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
Vaxelis
n=128 Participants
Participants received 0.5 mL doses of Vaxelis® (3.0 µg/mL PRP-OMP + diphtheria, tetanus, pertussis \[acellular, component\], poliomyelitis \[inactivated\], and hepatitis B \[recombinant deoxyribonucleic acid (rDNA)) administered intramuscularly at age 2 months, 4 months and 6 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
|---|---|---|
|
Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 151
|
106 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIBPopulation: All specimens from which valid concentration measurements were made from participants adhering to study procedures and intervals between primary doses, as defined in the protocol.
Describe the percent of infants with anti-PRP IgG ≥1.0 µg/mL on Day 151 after initiation of the primary series, i.e., 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB.
Outcome measures
| Measure |
PedvaxHIB Arm
n=117 Participants
Participants received 0.5 mL doses of PedvaxHIB® (7.5 µg/mL PRP-OMP) administered intramuscularly at age 2 months and 4 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
Vaxelis
n=128 Participants
Participants received 0.5 mL doses of Vaxelis® (3.0 µg/mL PRP-OMP + diphtheria, tetanus, pertussis \[acellular, component\], poliomyelitis \[inactivated\], and hepatitis B \[recombinant deoxyribonucleic acid (rDNA)) administered intramuscularly at age 2 months, 4 months and 6 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
|---|---|---|
|
Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 151
|
84 Participants
|
107 Participants
|
Adverse Events
PedvaxHIB Arm
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Vaxelis
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PedvaxHIB Arm
n=166 participants at risk
Participants received 0.5 mL doses of PedvaxHIB® (7.5 µg/mL PRP-OMP) administered intramuscularly at age 2 months and 4 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
Vaxelis
n=167 participants at risk
Participants received 0.5 mL doses of Vaxelis® (3.0 µg/mL PRP-OMP + diphtheria, tetanus, pertussis \[acellular, component\], poliomyelitis \[inactivated\], and hepatitis B \[recombinant deoxyribonucleic acid (rDNA)) administered intramuscularly at age 2 months, 4 months and 6 months along with their other routine immunizations according to the U.S. vaccination schedule for children.
|
|---|---|---|
|
Gastrointestinal disorders
Acute gastroenteritis
|
0.00%
0/166 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
0.60%
1/167 • Number of events 1 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
|
Musculoskeletal and connective tissue disorders
Broken Femur
|
0.60%
1/166 • Number of events 1 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
0.00%
0/167 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis
|
4.8%
8/166 • Number of events 9 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
2.4%
4/167 • Number of events 4 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
1.2%
2/166 • Number of events 2 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
0.60%
1/167 • Number of events 1 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
1.2%
2/166 • Number of events 2 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
0.00%
0/167 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
|
Nervous system disorders
Serizure, or seizure-like activity
|
0.00%
0/166 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
1.2%
2/167 • Number of events 2 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/166 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
0.60%
1/167 • Number of events 1 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
|
Infections and infestations
Viral illness with hypoxia
|
0.60%
1/166 • Number of events 1 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
0.00%
0/167 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
|
Respiratory, thoracic and mediastinal disorders
Viral Upper Respiratory Tract Infection
|
0.00%
0/166 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
0.60%
1/167 • Number of events 1 • Up to 7 months post first dose of study vaccine
SAEs were assessed via parental questionnaire and chart review at each study visit. SAEs were assessed for severity and causality by the Investigators. Non-serious adverse events were not monitored.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place