Phase 4 N=333 Randomized Prevention

Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study)

Haemophilus Influenzae Type B Infection

Bottom Line

View on ClinicalTrials.gov: NCT04978818 ↗

Enrolled (actual)

333

Serious AEs

6.3%

Results posted

Jun 2024

Primary outcome: Primary: Anti-PRP IgG Geometric Mean Concentration (GMC) — 0.40; 0.41 μg/mL — p=0.85

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Vaxelis (Drug); PedvaxHIB (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Johns Hopkins Bloomberg School of Public Health
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Anti-PRP IgG Geometric Mean Concentration (GMC)	0.40; 0.41	0.85
SECONDARY Percent of Anti-PRP IgG ≥0.15 µg/mL 30 Days After Dose 1	104; 115	0.39
SECONDARY Percent of Anti-PRP IgG ≥1.0 µg/mL 30 Days After Dose 1	40; 38	0.64
SECONDARY Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 121	115; 126	0.87
SECONDARY Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 121	100; 102	0.3
SECONDARY Percent of Anti-PRP IgG ≥0.15 µg/mL on Day 151	106; 122	0.15
SECONDARY Percent of Anti-PRP IgG ≥1.0 µg/mL on Day 151	84; 107	0.03 sig

Summary

The main goal of this study is to compare the Haemophilus influenzae type b antibody response in American Indian / Alaska Native (AI/AN) infants to two licensed vaccines: Vaxelis and PedvaxHIB.

Eligibility Criteria

Inclusion Criteria

Born at gestational age of ≥35 weeks
AI/AN infant between 6 to 12 weeks of age (42-90 days) at the time of the first vaccination (i.e., Study Day 1)
Written informed consent provided by parent(s)/Legally Authorized Representative(s) (LARs)
Investigators believe that the parent(s)/LARs can and will comply with the requirements of the protocol (i.e., return for follow-up visits, recall of adverse events)
Infant is available to complete the follow-up period of 5 months
Healthy infant, as established by medical history and clinical examination before entering the study

Exclusion Criteria

History of receipt of blood, blood products, or immunoglobulin products since birth or expected receipt through the duration of the study
Chronic seizure or evolving or unstable neurologic disorder
Congenital Heart Disease, except for uncomplicated CHD (e.g., PDA, small septal defect)
Infant of mother with HIV infection
History of reaction or hypersensitivity likely to be exacerbated by any vaccine component, or to latex
Infant with confirmed or suspected immunocompromising medical condition, based on medical history, including chronic administration (more than 14 days in the lifetime) of immunosuppressants or other immune-modifying drugs since birth
Administration of infant vaccines other than birth dose Hepatitis B, prior to the time of enrollment
Any condition which might interfere with the evaluation of the investigational product, or interpretation of subject safety or study results, in the opinion of the investigator
Child of an employee of the sponsor, clinical study site, or any other individual involved with the conduct of the study, or an immediate family member of such individuals
Acute illness and/or fever (temperature ≥100.4 F or ≥38.0 C) at time of enrollment (Note: Participant with fever may be enrolled at later date if symptoms have resolved and all other criteria for inclusion are met at that time)
Current (or within the past 7 days) or expected receipt of immunosuppressive agents, including steroids, except topical or inhaled steroids (Note: For oral corticosteroids, this will mean prednisone (≥ 0.5 mg/kg/day, or equivalent; participant may be enrolled at a later date if medication use ends and all other criteria for inclusion are met at that time)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04978818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.