Phase 4
Completed N=400
Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination
Source: ClinicalTrials.gov NCT01357720 ↗Enrolled (actual)
400
Serious AEs
0.5%
Results posted
May 2013
Primary outcomePrimary: Seroprotection Rate: Anti-PRP Antibodies — 100; 100 percentage of subjects
Summary
This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for all 3 doses, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) 1 month after completion of the 6-10-14 week vaccination course.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroprotection Rate: Anti-PRP Antibodies |
100; 100 | — |
| PRIMARY Seroprotection Rate: Anti-hepatitis B Surface Antibodies |
94.9; 97.4 | — |
| PRIMARY Seroprotection Rate: Anti-diphtheria Toxoid Antibodies |
99.5; 100 | — |
| PRIMARY Seroprotection Rate: Anti-tetanus Toxoid Antibodies |
100; 100 | — |
| PRIMARY Seroprotection Rate: Anti-B. Pertussis Antibodies |
99.0; 100 | — |
Eligibility Criteria
Inclusion Criteria
- A male or female between, and including, 42 and 64 days of age at the time of the first vaccination
- Written informed consent obtained from parents/legal guardian of the subject
- Free of obvious health problems as established by medical history and/or clinical examination before entering the study
- Hepatitis B vaccination at birth (within 48 hours) Available for all scheduled study visits
Exclusion Criteria
- Use of any investigational drug or any investigational vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up
- Planned administration of a vaccine not foreseen by the study protocol
- Known or suspected impairment of immune function, known Human immunodeficiency virus (HIV)-positivity, receiving immunosuppressive therapy, or having received systemic immunosuppressive therapy within 1 month prior to study entry (note: inhaled and topical steroids are allowed)
- Administration of parenteral immunoglobulin preparation and/or blood products since birth
- Previous vaccination against Haemophilus influenzae type b (Hib) and/or diphtheria, tetanus, pertussis (DTP)
- History of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component or to products containing mercury compounds, such as sodium ethylmercuro-thiosalicylate
- Significant acute infection
- Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- Participation in another clinical study
Data sourced from ClinicalTrials.gov (NCT01357720). 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.