Phase 3
N=131
Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B
Diphtheria · Pertussis · Tetanus · Hepatitis B · Haemophilus Influenzae Infections
Bottom Line
View on ClinicalTrials.gov: NCT01362517 ↗Enrolled (actual)
131
Serious AEs
2.8%
Results posted
Jun 2013
Primary outcome: Primary: Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component — 93.1; 99.2; 98.5; 93.1 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Quinvaxem (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Crucell Holland BV
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component |
88.4; 49.6; 82.2; 76.7; 97.7 | — |
| PRIMARY Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component |
88.4; 49.6; 82.2; 76.7; 97.7 | — |
| SECONDARY Safety: Adverse and Serious Adverse Events |
5.6; 2.8; 4.1; 18.4; 0.3; 2.6 | — |
Summary
The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4 months of age according to the local Expanded Programme on Immunisation (EPI) schedule
Eligibility Criteria
Inclusion Criteria
- Infants are at age of DTP vaccination of the local EPI program (60-120 days old) and free from any obvious health problems
- Have a normal gestational age (≥ 37 weeks); birth weight > 2.5 kg
- There is no congenital disease detected through interview and clinical examination
- Already had or not yet received Hepatitis B vaccination at birth
- Do not have dermatological diseases such as eczema, allergies
- Parent or legal guardian voluntarily provides consent for their child for participation in the study by signing the informed consent and agrees to comply with all study procedures
Exclusion Criteria
- Already vaccinated with DTP vaccine
- Have an acute infection at the time of study vaccination
- Contraindications to Quinvaxem
- Receiving treatment with systemic corticosteroids
- Currently participating in another clinical trial
- In receipt of a parenteral immunoglobulin preparation and/or blood/blood products since birth
- Parents intend to move to another location during the study (the next 12 months)
Data sourced from ClinicalTrials.gov (NCT01362517). 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.