NCT01357720

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 22, 2013

Completed
Last Updated

September 9, 2013

Status Verified

August 1, 2013

Enrollment Period

4 months

First QC Date

May 19, 2011

Results QC Date

March 27, 2013

Last Update Submit

August 29, 2013

Conditions

DiphtheriaPertussisTetanusHepatitis BHaemophilus Infections

Keywords

VaccinationImmunisationVirusDiphtheriaPertussisTetanusHepatitis BHaemophilus InfluenzaeImmunity

Outcome Measures

Primary Outcomes (5)

  • Seroprotection Rate: Anti-PRP Antibodies

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

    1 month after the third vaccination

  • 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)

    1 month after the third vaccination

  • Seroprotection Rate: Anti-diphtheria Toxoid Antibodies

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

    1 month after the third vaccination

  • Seroprotection Rate: Anti-tetanus Toxoid Antibodies

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

    1 month after the third vaccination

  • 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)

    1 month after the third vaccination

Study Arms (2)

Quinvaxem

EXPERIMENTAL
Biological: Quinvaxem

Tritanrix Hib/HepB + Quinvaxem

ACTIVE COMPARATOR
Biological: Quinvaxem/Tritanrix

Interventions

QuinvaxemBIOLOGICAL

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
Quinvaxem/TritanrixBIOLOGICAL

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

Tritanrix Hib/HepB + Quinvaxem

Eligibility Criteria

Age42 Days - 64 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute for Tropical Medicine

City of Muntinlupa, Philippines

Location

Related Publications (1)

  • Capeding MR, Jica C, Macura-Biegun A, Rauscher M, Alberto E. Interchangeability of Quinvaxem during primary vaccination schedules: results from a phase IV, single-blind, randomized, controlled, single-center, non-inferiority study. Vaccine. 2014 Feb 7;32(7):888-94. doi: 10.1016/j.vaccine.2013.10.059. Epub 2013 Oct 29.

    PMID: 24176498DERIVED

MeSH Terms

Conditions

DiphtheriaWhooping CoughTetanusHepatitis BHaemophilus InfectionsVirus Diseases

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesClostridium InfectionsBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesPasteurellaceae Infections

Results Point of Contact

Title
Medical Affairs Director
Organization
Crucell Switzerland AG
info@crucell.com
+41(0)319086111

Study Officials

  • Maria RZ Capeding, MD

    Research Institute for Tropical Medicine (RITM)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2011

First Posted

May 23, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 9, 2013

Results First Posted

May 22, 2013

Record last verified: 2013-08

Locations

PH(1)