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Clinical Trials/EUCTR2015-005353-12-Outside-EU/EEA
EUCTR2015-005353-12-Outside-EU/EEA
Active, not recruiting
Not Applicable

Immunogenicity and Safety of the DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 2, 3 and 4 Months of Age or 3, 4 and 5 Months of Age and followed by a Booster Dose at 18 to 20 Months, as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in infants in People’s Republic of China

SANOFI PASTEUR SA0 sites792 target enrollmentDecember 4, 2015
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ConditionsHealthy volunteers: active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b (such as meningitis, septicaemia, cellulitis, arthritis, epiglottitis, pneumopathy, osteomyelitis)MedDRA version: 18.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsPENTAXIM™Act-HIB™IMOVAX Polio™Diphteria, Tetanus and Acellular Pertussis Combined Vaccine, Absorbed

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy volunteers: active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b (such as meningitis, septicaemia, cellulitis, arthritis, epiglottitis, pneumopathy, osteomyelitis)
Sponsor
SANOFI PASTEUR SA
Enrollment
792
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 4, 2015
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
SANOFI PASTEUR SA

Eligibility Criteria

Inclusion Criteria

  • •1\) Aged 2 months (60 to 74 days) inclusive on the day of inclusion
  • •2\) Born at full term pregnancy (\= 36 weeks) with a birth weight \= 2\.5 kg
  • •3\) Informed consent form signed by the parent(s) or other legal representative
  • •4\) Able to attend all scheduled visits and to comply with all trial procedures
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 792
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\) Participation in another clinical trial in the 4 weeks preceding the trial inclusion
  • •2\) Planned participation in another clinical trial during the present trial period
  • •3\) Congenital or acquired immunodeficiency, immunosuppressive therapy such as long\-term systemic corticosteroids therapy
  • •4\) Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
  • •5\) Chronic illness at a stage that could interfere with trial conduct or completion
  • •6\) Blood or blood–derived products received in the past
  • •7\) Any vaccination performed or planned in the 4 weeks preceding the first trial visit (except BCG and Hepatitis B, which can not be given within 8 days before the first study visit)
  • •8\) Vaccination planned in the 4 weeks following any trial vaccination (except BCG and Hepatitis B, which can not be given within 8 days before or after the study vaccine(s) administration)
  • •9\) History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically)
  • •10\) Clinical or serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection

Outcomes

Primary Outcomes

Not specified

Similar Trials

Unknown
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Active, not recruiting
Not Applicable
Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in ChinaHealthy volunteers: active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b (such as meningitis, septicaemia, cellulitis, arthritis, epiglottitis, pneumopathy, osteomyelitis)MedDRA version: 18.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
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