Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China
This study has been completed.
Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01491087
First received: December 9, 2011
Last updated: March 28, 2013
Last verified: March 2013
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Purpose
The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at 2, 3, and 4 months of age in order to meet the regulatory requirements for the license renewal as for any other product registered in China, and to generate additional clinical data using the three-dose primary vaccination schedule in some other Chinese provinces.
Primary Objective
- To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in the study population.
| Condition | Intervention | Phase |
|---|---|---|
|
Diphtheria Tetanus Pertussis Polio |
Biological: DTacP IPV//PRP~T combined vaccine: PENTAXIM® |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | 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 in Infants in China |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Description of the Safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with PENTAXIM® vaccine [ Time Frame: Day 0 for up to 3 months post vaccination ] [ Designated as safety issue: No ]Solicited injection site: Tenderness, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability
| Enrollment: | 900 |
| Study Start Date: | December 2011 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PENTAXIM® vaccine group |
Biological: DTacP IPV//PRP~T combined vaccine: PENTAXIM®
0.5 mL, Intramuscular
Other Name: PENTAXIM®
|
Detailed Description:
Each study participant will receive an injection of PENTAXIM® at 2, 3, and 4 months of age and will be monitored for safety through the entire study period.
The duration of each participant in the trial will be approximately 3 to 4 months.
Eligibility| Ages Eligible for Study: | 60 Days to 74 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Aged 2 months (60 to 74 days) inclusive 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
- Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
- Participation or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
- Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
- Clinically significant illness, according to investigator judgment, at a stage that could interfere with trial conduct or completion
- Evolving encephalopathy
- Receipt of immune globulins, blood or blood-derived products since birth
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection
- Receipt of any other vaccine in the 14 days preceding the first trial vaccination or planned receipt of any vaccine in the 14 days following the first trial vaccination
- Acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- Contraindications to vaccination according to PENTAXIM® summary of product characteristics (SPC) or leaflet
- In an emergency setting, or hospitalized involuntarily
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491087
Locations
| China, Guangdong | |
| Guangzhou, Guangdong, China, 510300 | |
| China | |
| Shanghai, China, 200336 | |
| Tianjin, China, 300011 | |
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
| Study Director: | Medical Director | Sanofi Pasteur SA |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
| ClinicalTrials.gov Identifier: | NCT01491087 History of Changes |
| Other Study ID Numbers: | E2I60, U1111-1117-7233 |
| Study First Received: | December 9, 2011 |
| Last Updated: | March 28, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Sanofi:
|
Pentaxim® Whole-cell Pertussis vaccine Acellular Pertussis vaccine |
Haemophilus influenzae type b polysaccharide Inactivated Polio vaccine Pentavac® |
Additional relevant MeSH terms:
|
Diphtheria Whooping Cough Poliomyelitis Tetanus Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections Infection Respiratory Tract Diseases |
Myelitis Central Nervous System Viral Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Clostridium Infections |
ClinicalTrials.gov processed this record on May 23, 2013