A clinical trial to describe the safety and immunogenicity of 13 valent pneumococcal conjugate vaccine formulated in multidose vials when given with routine pediatric vaccines in healthy infants in India.Title intended for the lay public in easily understood language.

Phase 4

Completed

Conditions: The prevention of disease caused by S pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F (including sepsis, meningitis, bacteremia, pneumonia, and acute otitis media)

Registration Number: CTRI/2017/08/009492

Lead Sponsor: Pfizer Limited Subsidiary of Pfizer Inc

Brief Summary: This is a phase 4, randomized, open label trial to describe the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) formulated in multidose vials when given with routine pediatric vaccines in healthy infants in India. This study is being conducted in response to a post approval marketing authorization condition by the Drugs Controller General of India (DCGI) vide letter 27-Jun-2016. Currently 13vPnC is available as a single dose prefilled syringe. Now Pfizer has developed a formulation containing the preservative 2-phenoxyethanol (2-PE) that will allow the vaccine to be supplied in a multi-dose vial presentation with 4 doses per vial. The multi-dose vial presentation with 2-PE will help significantly reduce the cold-chain requirements, storage costs and wastage incurred in delivering the vaccine through large scale public immunization programs.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 300

Inclusion Criteria

Evidence of a personally signed and dated informed consent document indicating that the parent(s)or legal guardian(s) has or have been informed of all pertinent aspects of the study.
Parent(s) or legal guardian(s) or caregiver(s) willing and able to comply with scheduled visits, treatment plan, and other study procedures.
Aged 6 weeks (42 to 72 days) at the time of vaccination.
(The day of birth is considered Day 0) 4.Available for the entire study period and whose parent(s) or legal guardian(s) or caregiver(s) can be reached by telephone.
Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria

Infant who is a direct descendant (child, grandchild) of â€¢ Investigator site staff members directly involved in the conduct of the study, or â€¢ Site staff members otherwise supervised by the investigator, or â€¢ Pfizer employees directly involved in the conduct of the study.
Participation in other studies involving investigational drug(s) within 28 days prior to study entry and or during study participation.
Participation in purely observational studies is acceptable.
Previous vaccination with licensed or investigational pneumococcal conjugate vaccine.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with pneumococcal conjugate vaccine, or any other vaccine or vaccine component.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
Known or suspected immune deficiency or suppression, including known human immunodeficiency virus infection.
Major known congenital malformation or serious chronic disorder.
Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders.
Does not include resolving syndromes due to birth trauma such as Erbâ€™s palsy.
Other acute or chronic medical condition including recent laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Receipt of blood products or gamma globulin (including hepatitis B immunoglobulin and monoclonal antibodies, eg, Synagis).
Inclusion and exclusion criteria for participant selection, including age and sex.
Age and sex to be mentioned in specific boxes.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe the safety profile of 13vPnC with 2-PE in the MDV group and without 2-PE in the PFS group	From 6 week visit to 1 month after the infant series (13 Month visit)
Primary Endpoint:	From 6 week visit to 1 month after the infant series (13 Month visit)
1. Incidence of local reactions and systemic events, Adverse events, serious adverse events and Incidence of newly diagnosed chronic medical conditions at defined time periods in the MDV group and in the PFS group	From 6 week visit to 1 month after the infant series (13 Month visit)

Secondary Outcome Measures

Name	Time	Method
To describe the pneumococcal immune responses	induced by 13vPnC with 2-PE in the MDV group and in the PFS group

Trial Locations

Locations (7): B.J Medical college and Civil Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Bharati Vidyapeeth University Medical College
🇮🇳
Pune, MAHARASHTRA, India
Kanchi Kamakoti Childs Trust Hospital
🇮🇳
Chennai, TAMIL NADU, India
KEM Hospital Research Centre
🇮🇳
Pune, MAHARASHTRA, India
Manipal Hospital
🇮🇳
Bangalore, KARNATAKA, India
Sir Ganga Ram Hospital
🇮🇳
Delhi, DELHI, India
Sri Ramachandra Hospital
🇮🇳
Chennai, TAMIL NADU, India
B.J Medical college and Civil Hospital
🇮🇳Ahmadabad, GUJARAT, India
Dr Bela Hasmukh Shah
Principal investigator
09879208977
bela_dr@yahoo.co.in