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History of Changes for Study: NCT01105559
Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine
Latest version (submitted December 12, 2011) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 15, 2010 None (earliest Version on record)
2 May 10, 2010 Recruitment Status, Study Status and Contacts/Locations
3 November 5, 2010 Recruitment Status, Study Status and Contacts/Locations
4 October 4, 2011 Sponsor/Collaborators, Study Design and Study Status
5 December 12, 2011 Recruitment Status and Study Status
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Study NCT01105559
Submitted Date:  April 15, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: A3L26
Brief Title: Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine
Official Title: Antibody Persistence in Healthy South African Children After Primary Series and Booster Vaccination With an Investigational (DTaP-IPV-Hep B-PRP-T) or Control Vaccines
Secondary IDs: UTN: U1111-1111-5789 [WHO]
Open or close this module Study Status
Record Verification: April 2010
Overall Status: Not yet recruiting
Study Start: April 2010
Primary Completion: November 2011 [Anticipated]
Study Completion: August 2012 [Anticipated]
First Submitted: April 15, 2010
First Submitted that
Met QC Criteria:
April 15, 2010
First Posted: April 16, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 15, 2010
Last Update Posted: April 16, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sanofi
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

The purpose of this study is to evaluate the long term immunogenicity produced in children by the investigational hexavalent vaccine (DTaP-IPV-Hep B-PRP-T) given in Study A3L15 (NCT 00362336).

Primary Objective: To describe the antibody long term 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 or CombAct-Hib™ + Oral poliovirus vaccine (OPV) + Engerix™ B vaccination at 6, 10 and 14 weeks of age and a booster vaccination of DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + OPV at 15-18 months

Detailed Description:

All participants must have received the primary series of vaccinations and a booster vaccination in Study A3L15 (NCT 00362336).

Participants will receive no vaccination in this study but will undergo immunologic assessments at 3.5 and 4.5 years of age.

Open or close this module Conditions
Conditions: Diphtheria
Tetanus
Whooping Cough
Hepatitis B
Poliomyelitis
Keywords: Diphtheria
Tetanus
Whooping cough
Hepatitis B
Poliomyelitis
Diphtheria-Tetanus-acellular Pertussis Vaccines
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 567 [Anticipated]
Number of Groups/Cohorts 3
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Group 1
Participants previously received 3 doses and a booster dose of the investigational vaccine DTaP IPV Hep B PRP-T.
Group 2
Participants previously received 3 doses CombAct-Hib™ + Engerix™ B + OPV and a booster dose of CombAct-Hib™ + Oral poliovirus vaccine (OPV) vaccine.
Group 3
Participants previously received 3 doses DTaP IPV Hep B PRP-T; a dose of Engerix™ B at birth, and a booster dose of DTaP IPV Hep B PRP-T vaccine.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The antibody titers for each valence of DTaP-IPV-Hep B-PRP-T vaccine (except poliovirus) post-primary and booster vaccination.
[ Time Frame: Age 3.5 and 4.5 years after infant and booster vaccination ]

Open or close this module Eligibility
Study Population: Participants aged 3 years and a half on the day of inclusion and must have received the primary series of vaccinations and a booster vaccination in Study A3L15 (NCT 00362336). No vaccination will be provided or administered in this study.
Sampling Method: Non-Probability Sample
Minimum Age: 41 Months
Maximum Age: 43 Months
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria :

  • Aged 3 years and a half on the day of inclusion (42 months ± 60 days)
  • Informed consent form signed by a parent or other legally acceptable representative and by an independent witness if the parent or other legal guardian is illiterate.
  • Subject and parent/ legally acceptable representative able to attend the scheduled visits and to comply with all trial procedures.
  • Receipt of primary vaccination with 3 doses of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + Oral poliovirus vaccine (OPV) + Engerix™ B and a booster dose of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™+ OPV.

Exclusion Criteria :

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the inclusion in the trial.
  • Incomplete primary and booster immunization at trial A3L15.
  • Previous confirmed clinical, serological, or microbiological diagnosis of diphtheria, tetanus, whooping cough, poliomyelitis, Haemophilus influenza b or hepatitis B after completion of A3L15 Study.
  • Subjects known to have received diphtheria, tetanus, pertussis, Haemophilus influenza b and hepatitis B vaccination after completion of A3L15 Study.
  • Any vaccination within 30 days preceding inclusion, except for measles or poliovirus (monovalent) containing vaccines and pandemic influenza vaccines including pandemic H1N1-2009 strain, which may be received at least two weeks before the subject's blood sample collection
  • Blood or blood-derived products received at the latest 3 months before inclusion, receipts of immunosuppressant drugs within the previous 3 months.
  • Known or suspected congenital or acquired immunodeficiency since completion of A3L15 Study.
  • Serious chronic illness occurring after receipt of the primary and booster series (e.g. leukemia, lymphoma [Tor B cells], Crohn's disease).
  • Known or suspected subject seroconversion for human immunodeficiency virus (HIV) or hepatitis C seropositivity since completion of A3L15 Study.
  • Febrile (temperature ≥ 38.0°C) or acute, moderate or severe systemic illness on the day of inclusion.
Open or close this module Contacts/Locations
Central Contact Person: Public Registry Sanofi Pasteur.
Email: RegistryContactUs@sanofipasteur.com
Study Officials: Medical Director
Study Director
Sanofi Pasteur Inc.
Locations: South Africa
Bertsham, South Africa, 2013
Johannesburg, South Africa
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Related Info
Available IPD/Information:

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