Clinical trial NCT03548337: 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
Official title: A PHASE 4, RANDOMIZED, OPEN-LABEL TRIAL 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaccines
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-06-07
Enrollment: 301
Sex: ALL
Minimum age (years): 42
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A Phase 4 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

Detailed description: A Phase 4, Randomized, Open-label Trial 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

Eligibility criteria: Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent document indicating that the parent(s)/legal guardian(s) has/have been informed of all pertinent aspects of the study.
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:

1. Infant who is a direct descendant (child, grandchild) of

   * 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).

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
timeFrame: Within 7 days after Vaccination 1
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
timeFrame: Within 7 days after Vaccination 1
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
timeFrame: Within 7 days after Vaccination 2
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
timeFrame: Within 7 days after Vaccination 2
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
timeFrame: Within 7 days after Vaccination 3
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
timeFrame: Within 7 days after Vaccination 3
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
timeFrame: Within 7 days after Vaccination 4
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
timeFrame: Within 7 days after Vaccination 4
measure: Percentage of Participants With Adverse Events (AEs) After Vaccination 1 up to 1 Month After Vaccination 3
timeFrame: From Vaccination 1 up to 1 Month after Vaccination 3 (for a maximum study duration of 3 months)
measure: Percentage of Participants With Adverse Events (AEs) From Vaccination 4 up to 1 Month After Vaccination 4
timeFrame: From Vaccination 4 up to 1 month after Vaccination 4 (for a maximum study duration of 1 month)
measure: Percentage of Participants With Serious Adverse Events (SAEs) After Vaccination 1 up to 1 Month After Vaccination 4
timeFrame: From Vaccination 1 up to 1 month after Vaccination 4 (for a maximum study duration of 11.5 months)
measure: Number of Participants With New Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Vaccination 3 up to Vaccination 4
timeFrame: From 1 month after Vaccination 3 up to Vaccination 4 (for a maximum study duration of 7.5 months)
Secondary outcomes:
measure: Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
timeFrame: 1 month after Vaccination 3
measure: Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
timeFrame: 1 month after Vaccination 4
measure: Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
timeFrame: 1 month after Vaccination 3
measure: Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
timeFrame: 1 month after Vaccination 4
measure: Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
timeFrame: 1 month after Vaccination 3
measure: Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
timeFrame: 1 month after Vaccination 4
measure: Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
timeFrame: 1 month after Vaccination 3
measure: Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
timeFrame: 1 month after Vaccination 4
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: B. J. Medical College & Civil Hospital
state: Gujarat
city: Bengaluru
country: India
facility: Manipal Hospital
state: Karnataka
city: Pune
country: India
facility: KEM Hospital Research Centre
state: Maharashtra
city: Pune
country: India
facility: Bharati Vidyapeeth University Medical College
state: Maharashtra
city: Chennai
country: India
facility: Sri Ramachandra Hospital
state: Tamil NADU
city: Chennai, Tamil Nadu
country: India
facility: Kanchi Kamakoti Childs Trust Hospital
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.