Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00303316
First received: March 13, 2006
Last updated: January 18, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diphtheria Tetanus Pertussis Poliomyelitis Hepatitis B |
Biological: DTaP-IPV//PRP~T combined vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Immunogenicity Study of the Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months of Age Following a Primary Series of DTaP-IPV-HB-PRP~T Combined Vaccine or of PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants |
Resource links provided by NLM:
MedlinePlus related topics:
Cough
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Polio and Post-Polio Syndrome
Tetanus
Whooping Cough
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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. [ Time Frame: Day 0 (Before booster vaccination) ] [ Designated as safety issue: No ]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).
- 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. [ Time Frame: Day 30 Post-booster Vaccination ] [ Designated as safety issue: No ]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.
- 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. [ Time Frame: Day 0 (pre-booster) and Day 30 post-booster ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ [ Time Frame: Day 0 up to Day 30 post-booster vaccination ] [ Designated as safety issue: No ]
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.
Grade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable.
| Enrollment: | 458 |
| Study Start Date: | February 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DTacP IPV HepB PRP-T Combined Vaccine Group
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
0.5 mL, Intramuscular
Other Name: PENTAXIM™
|
|
Active Comparator: PENTAXIM™ and ENGERIX B® Vaccine Group
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
0.5 mL, Intramuscular
Other Name: PENTAXIM™
|
Eligibility| Ages Eligible for Study: | 510 Days to 578 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Fever (axillary temperature ≥37.4°C or equivalent rectal temperature ≥38.0°C) or acute illness on the day of inclusion
- 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
- Axillary temperature >39.4°C or equivalent rectal temperature > 40.0°C within 48 hours following vaccine injection.
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00303316 History of Changes |
| Other Study ID Numbers: | A3L16 |
| Study First Received: | March 13, 2006 |
| Results First Received: | December 11, 2012 |
| Last Updated: | January 18, 2013 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Keywords provided by Sanofi:
|
Diphtheria Tetanus Pertussis whooping cough |
Haemophilus influenzae type b Hepatitis B Poliomyelitis |
Additional relevant MeSH terms:
|
Diphtheria Hepatitis Hepatitis A Hepatitis B Whooping Cough Poliomyelitis Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections Infection Respiratory Tract Diseases Myelitis Central Nervous System Viral Diseases Central Nervous System Infections Central Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013