Phase 3 Completed N=131 Treatment

Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B

Diphtheria · Pertussis · Tetanus · Hepatitis B

Source: ClinicalTrials.gov NCT01362517 ↗

Enrolled (actual)

131

Serious AEs

2.8%

Results posted

Jun 2013

Primary outcomePrimary: Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component — 93.1; 99.2; 98.5; 93.1 percentage of subjects

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

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	—
SECONDARY Safety: Adverse and Serious Adverse Events	5.6; 2.8; 4.1; 18.4; 0.3; 2.6	—

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)

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.