Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
NCT ID: NCT03548337
Last Updated: 2020-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
301 participants
INTERVENTIONAL
2018-05-31
2019-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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13vPnC with 2-PE from a MDV
Multi Dose Vial with preservative
13vPnC
13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative
13vPnC without 2-PE in a PFS
Pre Filled Syringe without preservative
13vPnC
13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative
Interventions
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13vPnC
13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative
Eligibility Criteria
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Inclusion Criteria
2. Parent(s)/legal guardian(s)/caregiver(s) willing and able to comply with scheduled visits, treatment plan, and other study procedures.
3. 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)/legal guardian(s)/caregiver(s) can be reached by telephone.
5. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
6. Weight of 3.0 kg or greater at the time of vaccination.
Exclusion Criteria
* Investigator site staff members directly involved in the conduct of the study, or
* Site staff members otherwise supervised by the investigator, or
* Pfizer employees directly involved in the conduct of the study.
2. 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.
3. Previous vaccination with licensed or investigational pneumococcal conjugate vaccine.
4. A previous anaphylactic reaction to any vaccine or vaccine-related component.
5. 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.
6. Known or suspected immune deficiency or suppression, including known human immunodeficiency virus infection.
7. Major known congenital malformation or serious chronic disorder.
8. 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 Erb's palsy.
9. 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.
10. Receipt of blood products or gamma globulin (including hepatitis B immunoglobulin and monoclonal antibodies, eg, Synagis).
42 Days
72 Days
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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B. J. Medical College & Civil Hospital
Ahmedabad, Gujarat, India
Manipal Hospital
Bengaluru, Karnataka, India
KEM Hospital Research Centre
Pune, Maharashtra, India
Bharati Vidyapeeth University Medical College
Pune, Maharashtra, India
Sri Ramachandra Hospital
Chennai, Tamil Nadu, India
Kanchi Kamakoti Childs Trust Hospital
Chennai, Tamil Nadu, , India
Sir Ganga Ram Hospital
New Delhi, , India
Countries
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References
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Lalwani SK, Ramanan PV, Sapru A, Sundaram B, Shah BH, Kaul D, Karthik Nagesh N, Kalina WV, Chand R, Ding M, Suroju S, Scott DA, Lockhart SP. Safety and immunogenicity of a multidose vial formulation of 13-valent pneumococcal conjugate vaccine administered with routine pediatric vaccines in healthy infants in India: A phase 4, randomized, open-label study. Vaccine. 2021 Nov 5;39(46):6787-6795. doi: 10.1016/j.vaccine.2021.09.029. Epub 2021 Oct 14.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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INDIA INFANT MDV
Identifier Type: OTHER
Identifier Source: secondary_id
2016-005134-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B4671004
Identifier Type: -
Identifier Source: org_study_id
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