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Completed

NCT Number: NCT01357720

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

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.

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Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Bordetella Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Pasteurellaceae Infections Pertussis Respiratory Tract Diseases Respiratory Tract Infections Tetanus Virus Diseases Whooping Cough

Age range

42 day–64 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Institute for Tropical Medicine

City of Muntinlupa, Philippines

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quinvaxem

Biological

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

Quinvaxem/Tritanrix

Biological

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 outcomes

  1. Seroprotection Rate: Anti-PRP Antibodies

    Time frame: 1 month after the third vaccination

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

  2. Seroprotection Rate: Anti-hepatitis B Surface Antibodies

    Time frame: 1 month after the third vaccination

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

  3. Seroprotection Rate: Anti-diphtheria Toxoid Antibodies

    Time frame: 1 month after the third vaccination

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

  4. Seroprotection Rate: Anti-tetanus Toxoid Antibodies

    Time frame: 1 month after the third vaccination

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

  5. Seroprotection Rate: Anti-B. Pertussis Antibodies

    Time frame: 1 month after the third vaccination

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

Sponsors and collaborators

Lead sponsor

Crucell Holland BV

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 23, 2011
Registry last updated
Sep 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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