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Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination

Primary Purpose

Diphtheria, Pertussis, Tetanus

Status

Completed

Phase

Phase 4

Locations

Philippines

Study Type

Interventional

Intervention

Quinvaxem

Quinvaxem/Tritanrix

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae, Immunity

Eligibility Criteria

42 Days - 64 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Research Institute for Tropical Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Quinvaxem

Tritanrix Hib/HepB + Quinvaxem

Arm Description

Outcomes

Primary Outcome Measures

Seroprotection Rate: Anti-PRP Antibodies

Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)

Seroprotection Rate: Anti-hepatitis B Surface Antibodies

Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)

Seroprotection Rate: Anti-diphtheria Toxoid Antibodies

Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)

Seroprotection Rate: Anti-tetanus Toxoid Antibodies

Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)

Seroprotection Rate: Anti-B. Pertussis Antibodies

Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)

Secondary Outcome Measures

Full Information

NCT ID

NCT01357720

First Posted

May 19, 2011

Last Updated

August 29, 2013

Sponsor

Crucell Holland BV

1. Study Identification

Unique Protocol Identification Number

NCT01357720

Brief Title

Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination

Official Title

A Phase IV, Single-blind, Randomized, Controlled, Monocentric Study to Assess the Interchangeability of Quinvaxem (DTwP-HepB-Hib) as the 2nd and 3rd Dose After Initial Vaccination With Tritanrix HB+Hib (DTwP-HepB/Hib) With Respect to Safety and Immunogenicity in Healthy Infants at 6, 10 and 14 Weeks of Age

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Crucell Holland BV

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Infections

Keywords

Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae, Immunity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Quinvaxem

Arm Type

Experimental

Arm Title

Tritanrix Hib/HepB + Quinvaxem

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Quinvaxem

Intervention Description

A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at Weeks 6, 10 and 14

Intervention Type

Biological

Intervention Name(s)

Quinvaxem/Tritanrix

Intervention Description

A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), inactive pertussis bacteria (>= 4 IU), 10 mcg Hib polysaccharide conjugate (approx. 25 mcg tetanus toxoid), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at Weeks 6, 10 and 14

Primary Outcome Measure Information:

Title

Seroprotection Rate: Anti-PRP Antibodies

Description

Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)

Time Frame