Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

Tetanus Clinical Trial

Official title:

Phase-II Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831311
• Other study ID #: A3L02
• Status: Completed
• Phase: Phase 2
• First received: January 27, 2009
• Last updated: November 21, 2013
• Start date: October 2004
• Est. completion date: March 2007

Study information

• Verified date: November 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

• To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series.

Secondary Objectives:

• To describe in each group the immunogenicity parameters one month after the three-dose primary series.

• To describe safety profile after each vaccination in both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 624
• Est. completion date: March 2007
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Days to 70 Days

Eligibility

Inclusion Criteria :

• Infant of either gender, aged 50 to 70 days inclusive

• Mother is negative for HBsAg

• Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg

• Written informed consent form signed by at least one parent or by another legal representative and an independent witness

• Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial.

Exclusion Criteria :

• Axillary temperature =37.1°C on the day of inclusion

• Current or planned enrolment in another clinical trial during the clinical trial period

• Known mother's history of Human Immunodeficiency Virus (HIV) infection

• Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (=0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days)

• Receipt of blood-derived products since birth

• Acute symptoms or severe chronic illness (e.g. cardiac, renal insufficiency, diabetes, auto immune disorders, congenital defect) that may interfere with conduct or completion of trial

• Occurrence of seizures since birth

• Hypersensitivity to any of the vaccine components

• Coagulopathy contraindicating intramuscular injection

• History of (documented) clinical or serological/microbiological confirmed infection due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b (Hib) or hepatitis B (HB) diseases

• History of vaccination against pertussis, tetanus, diphtheria, polio, Hib or HB infections

• Vaccination within the last 4 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type b
• Pertussis
• Poliomyelitis
• Tetanus

Intervention

Biological:
• DTaP-IPV-HB-PRP~T
0.5 mL, Intramuscular
• DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
0.5 mL, Intramuscular (right and left thighs, respectively)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Argentina, 

References & Publications (1)

Tregnaghi MW, Zambrano B, Santos-Lima E. Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-mont — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®	Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as = 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.	1 month post last vaccination	No
Primary	Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®	Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies.; Seroprotection was defined as titers = 10 mIU/mL for anti-Hepatitis Bs, = 0.15 µg/mL for anti-PRP, = 0.01 IU/mL for anti-tetanus and anti-diphtheria, and = 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination.	Day 150 (1 month post-vaccination 3)	No
Primary	Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®	Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).	Day 150 (1 month post-vaccination 3)	No
Primary	Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®	Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).	Day 150 (1 month post-vaccination 3)	No
Secondary	Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™	Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and PENTAXIM™ injection sites	Day 0 up to Day 7 post-vaccination	No
Secondary	Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®	Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and ENGERIX B® injection sites.	Day 0 up to Day 7 post-vaccination	No
Secondary	Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®	Solicited systemic reactions: Pyrexia (temperature), Somnolence, Irritability, Anorexia, Vomiting not otherwise specified (NOS), Diarrhea NOS, and Crying were assessed in each participant following vaccination.; Grade 3 reactions defined as: Pyrexia (temperature), = 39.1°C; Somnolence, sleeping most of the time; Irritability, continuously irritable for = 3 hours; Anorexia, refused most or all feeds; Vomiting NOS, frequent vomiting and inability to have any oral intake; Diarrhea NOS, multiple liquid stools without any solid material; and Crying, persistent, inconsolable cry = 3 hours and/or high-pitched cry.	Day 0 up to Day 7 post-vaccination	No

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