NCT01983540

Brief Summary

This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722) and booster vaccination in Study A3L27 (NCT01444781). Study Objective:

  • To describe the long-term antibody persistence at 3.5 and 4.5 years of age following a 3-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) +Rotarix™ or Infanrix hexa™+Prevenar™ (PCV7) +Rotarix™ vaccination at 2, 4, 6 months of age and a booster vaccination of DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) or Infanrix hexa™+Prevenar™ (PCV7) at 12 to 24 months of age. Observational Objectives:
  • To describe the long-term antibody persistence by group and by stratification on the age at inclusion of the A3L27 booster study.
  • To describe the effect of one additional oral dose of stand alone poliovirus isotypes 1, 2 and 3 vaccine\* on the antibody persistence immune response for poliovirus isotypes (4 vs 5 doses of poliovirus administered).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
558

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

1.7 years

First QC Date

November 7, 2013

Last Update Submit

January 4, 2016

Conditions

DiphtheriaTetanusWhooping CoughHepatitis BPoliomyelitisHaemophilus Influenzae Type b

Keywords

DiphtheriaTetanusWhooping CoughHepatitis BPoliomyelitisPediatric combined vaccine

Outcome Measures

Primary Outcomes (1)

  • Summary of antibody persistence (for all valences) before the booster doses of DTaP-IPV-Hep B-PRP~T vaccine and Infanrix hexa™ vaccine

    Anti-D concentrations, ≥0.01 IU/mL, ≥0.1 IU/mL and ≥1.0 IU/mL: Anti-T antibody concentrations ≥0.01 IU/mL, ≥0.1 IU/mL and ≥ 1.0 IU/mL; Anti-Hep B antibody concentrations ≥10 mIU/mL and ≥100 mIU/mL; Anti-PRP antibody concentrations ≥0.15 µg/mL and ≥1.0 µg/mL; Anti-pertussis toxin antibody and anti-filamentous haemagglutinin (FHA) antibody concentrations Lower Limit of Quantitation (LLOQ), ≥2x LLOQ and ≥4x LLOQ and Anti-poliovirus 1, 2, and 3 antibody titers ≥8 (1/dil)

    Up to 60 days following enrollment

Secondary Outcomes (1)

  • Summary of antibody persistence (for all valences) before the booster doses of DTaP-IPV-Hep B-PRP~T vaccine and Infanrix hexa™ vaccine

    Up to 12 months following enrollment

Study Arms (3)

Study Group 1

EXPERIMENTAL

Participants who received 3 doses of DTaP-IPV-Hep B-PRP\~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of the same investigational vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study.

Biological: DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine

Study Group 2

EXPERIMENTAL

Participants who received 3 doses of DTaP-IPV-Hep B-PRP\~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of Infanrix hexa vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study.

Biological: DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine

Study Group 3

ACTIVE COMPARATOR

Participants who received 3 doses of Infanrix hexa vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of DTaP-IPV-Hep B-PRP\~T vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study.

Biological: Infanrix hexa + Prevenar + Rotarix vaccine

Interventions

DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccineBIOLOGICAL

DTaP-IPV-Hep B-PRP\~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age), and a booster of the same investigational vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study

Study Group 1
DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccineBIOLOGICAL

DTaP-IPV-Hep B-PRP\~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age) and a booster dose of Infanrix hexa vaccine with Prevnar at 12 to 24 months of age in a previous study.

Study Group 2
Infanrix hexa + Prevenar + Rotarix vaccineBIOLOGICAL

Infanrix hexa vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age), and a booster dose of DTaP-IPV-Hep B-PRP\~T vaccine concomitantly with Prevenar vaccine concomitantly with Prevenar at 12 to 24 months of age in a previous study.

Study Group 3

Eligibility Criteria

Age42 Months - 54 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 3 years and a half (42 months ± 60 days) on the day of the first study visit
  • Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness/es if required by local regulations)
  • Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
  • Receipt of primary vaccination with 3 doses of investigational vaccines during the primary series trial A3L24 (either DTaP-IPV-Hep B-PRP-T or Infanrix hexa, concomitantly administered with Prevenar \[PCV7\] and Rotarix) and a booster dose during the trial A3L27 (either DTaP-IPV-Hep B-PRP-T or Infanrix hexa, concomitantly administered with Prevenar \[PCV7\]).

You may not qualify if:

  • Participation at the time of study enrollment (or in the 4 weeks preceding the first trial visit) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Incomplete primary and booster immunization at trial A3L24 and A3L27
  • Receipt of any vaccine in the 4 weeks preceding the first trial visit or planned receipt of any vaccine in the 4 weeks preceding the second trial visit
  • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections with other vaccine(s) after completion of A3L27 study
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection(s), confirmed either clinically, serologically, or microbiologically after completion of trial A3L27
  • Acute or chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Cali, Colombia

Location

Unknown Facility

San José, Costa Rica

Location

Related Links

MeSH Terms

Conditions

DiphtheriaTetanusWhooping CoughHepatitis BPoliomyelitisHaemophilus Infections

Interventions

Heptavalent Pneumococcal Conjugate VaccineRIX4414 vaccinediphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pneumococcal VaccinesStreptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Study Officials

  • Medical Director

    Sanofi Pasteur Inc

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 14, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

CO(1)