NCT00303316

Brief Summary

This study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated in an earlier study in order to determine if they are still protected before they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the quality of the induced immune memory in response to a booster dose of the same vaccine as in the primary series. Primary Objective: To describe the antibody persistence at 18 months of age and the booster effect of a dose of PENTAXIM™ on immunogenicity. Secondary objective: To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by the vaccines received during the primary series.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
458

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2006

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

February 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

February 22, 2013

Completed
Last Updated

February 22, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

March 13, 2006

Results QC Date

December 11, 2012

Last Update Submit

January 18, 2013

Conditions

DiphtheriaTetanusPertussisPoliomyelitisHepatitis B

Keywords

DiphtheriaTetanusPertussiswhooping coughHaemophilus influenzae type bHepatitis BPoliomyelitis

Outcome Measures

Primary Outcomes (3)

  • Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.

    Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).

    Day 0 (Before booster vaccination)

  • Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.

    Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value.

    Day 30 Post-booster Vaccination

  • Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.

    Antibody titers determination: Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay.

    Day 0 (pre-booster) and Day 30 post-booster

Secondary Outcomes (1)

  • Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™

    Day 0 up to Day 30 post-booster vaccination

Study Arms (2)

DTacP IPV HepB PRP-T Combined Vaccine Group

EXPERIMENTAL

Participant will receive a booster dose of PENTAXIM™ having received DTacP-IPV-HepB-PRP-T (primary series) in Study A3L02.

Biological: DTaP-IPV//PRP~T combined vaccine

PENTAXIM™ and ENGERIX B® Vaccine Group

ACTIVE COMPARATOR

Participant will receive a booster dose of PENTAXIM™ having received ENGERIX B® and PEDIATRICO in Study A3L02 (Primary series)

Biological: DTaP-IPV//PRP~T combined vaccine

Interventions

DTaP-IPV//PRP~T combined vaccineBIOLOGICAL

0.5 mL, Intramuscular

Also known as: PENTAXIM™
DTacP IPV HepB PRP-T Combined Vaccine Group

Eligibility Criteria

Age510 Days - 578 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Toddler at 18 months of age (range: 510 days to 578 days of age inclusive)
  • Participated in study A3L02 (NCT00831311) and has completed the three-dose primary series with either diphtheria, tetanus, pertussis (2-component acellular), recombinant Hepatitis B Hansenula and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T) or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 months of age
  • Written informed consent form signed by at least one parent or by a legal representative and an independent witness
  • Able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if:

  • Participation in another clinical trial in the four weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroids therapy
  • Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances
  • Chronic illness at a stage that could interfere with trial conduct or completion
  • Blood or blood-derived products received in the last six months
  • Any vaccination in the four weeks preceding the trial
  • Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B antigen, since the end of the primary series
  • History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B infection(s) (confirmed either clinically, serologically, or microbiologically)
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
  • History of seizures
  • Known contraindication to further vaccination with a pertussis vaccine such as:
  • Encephalopathy; Inconsolable crying for \>3 hours within 48 hours following vaccine injection
  • Hypotonic hyporesponsive episode within 48 hours following vaccine injection
  • Seizures with or without fever within three days following vaccine injection
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Córdoba, Córdoba Province, 5000, Argentina

Location

Related Publications (1)

  • Tregnaghi M, Zambrano B, Santos-Lima E. Antibody persistence after a primary series of a new DTaP-IPV-Hep B-PRP-T combined vaccine or separate DTaP-IPV//PRP-T and hepatitis B vaccines at 2, 4, and 6 months of age and the effect of a subsequent DTaP-IPV//PRP-T booster vaccination at 18 months of age in healthy Argentinean infants. Pediatr Infect Dis J. 2012 Jan;31(1):e24-30. doi: 10.1097/INF.0b013e318242460a.

    PMID: 22157567RESULT

Related Links

MeSH Terms

Conditions

DiphtheriaTetanusWhooping CoughPoliomyelitisHepatitis BHaemophilus Infections

Interventions

Pentavac

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsClostridium InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesMyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesPasteurellaceae Infections

Results Point of Contact

Title
Medical Director
Organization
Sanofi Pasteur Inc.
RegistryContactUs@sanofipasteur.com

Study Officials

  • Clinical Trials

    Sanofi Pasteur, a Sanofi Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2006

First Posted

March 16, 2006

Study Start

February 1, 2006

Primary Completion

April 1, 2007

Study Completion

September 1, 2007

Last Updated

February 22, 2013

Results First Posted

February 22, 2013

Record last verified: 2013-01

Locations

AR(1)