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

NCT03548337 | Completed Phase 4 Results

• 3 other identifiers: B4671004INDIA INFANT MDV2016-005134-29
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 7

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

Conditions

Vaccines

Outcome Measures

Primary Outcomes (12)

• Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1

  Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 centimeters \[cm\]), moderate (2.5 to 7.0 cm) and, severe (greater than \[\>\] 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.

  Within 7 days after Vaccination 1

• Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1

  Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability,were recorded daily using an electronic diary. Fever graded as:1)less than (\<)38.0 degrees Celsius \[C\], 2)greater than or equal to(\>=)38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as:mild(increased or prolonged sleeping bouts), moderate(slightly subdued; interfering with daily activity), and severe(disabling; not interested in usual daily activity). Irritability graded as: mild(easily consolable), moderate(required increased attention), and severe(inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here,"Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.

  Within 7 days after Vaccination 1

• Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2

  Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.

  Within 7 days after Vaccination 2

• Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2

  Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.

  Within 7 days after Vaccination 2

• Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3

  Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.

  Within 7 days after Vaccination 3

• Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3

  Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.

  Within 7 days after Vaccination 3

• Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4

  Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.

  Within 7 days after Vaccination 4

• Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4

  Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.

  Within 7 days after Vaccination 4

• Percentage of Participants With Adverse Events (AEs) After Vaccination 1 up to 1 Month After Vaccination 3

  An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship.

  From Vaccination 1 up to 1 Month after Vaccination 3 (for a maximum study duration of 3 months)

• Percentage of Participants With Adverse Events (AEs) From Vaccination 4 up to 1 Month After Vaccination 4

  An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship.

  From Vaccination 4 up to 1 month after Vaccination 4 (for a maximum study duration of 1 month)

• Percentage of Participants With Serious Adverse Events (SAEs) After Vaccination 1 up to 1 Month After Vaccination 4

  An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  From Vaccination 1 up to 1 month after Vaccination 4 (for a maximum study duration of 11.5 months)

• Number of Participants With New Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Vaccination 3 up to Vaccination 4

  A newly diagnosed chronic medical condition was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From 1 month after Vaccination 3 up to Vaccination 4 (for a maximum study duration of 7.5 months)

Secondary Outcomes (8)

• 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

  1 month after Vaccination 3

• 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

  1 month after Vaccination 4

• Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3

  1 month after Vaccination 3

• Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4

  1 month after Vaccination 4

• Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3

  1 month after Vaccination 3

Study Arms (2)

13vPnC with 2-PE from a MDV

ACTIVE COMPARATOR

Multi Dose Vial with preservative

Biological: 13vPnC

13vPnC without 2-PE in a PFS

ACTIVE COMPARATOR

Pre Filled Syringe without preservative

Biological: 13vPnC

Interventions

13vPnC BIOLOGICAL

13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative

13vPnC with 2-PE from a MDV; 13vPnC without 2-PE in a PFS

Eligibility Criteria

• Age: 42 Days - 72 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Parent(s)/legal guardian(s)/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.)
• Available for the entire study period and whose parent(s)/legal guardian(s)/caregiver(s) can be reached by telephone.
• Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
• Weight of 3.0 kg or greater at the time of vaccination.

You may not qualify if:

• 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.
• 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 Erb'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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

B. J. Medical College & Civil Hospital

Ahmedabad, Gujarat, 380016, India

Location

Manipal Hospital

Bengaluru, Karnataka, 560017, India

Location

KEM Hospital Research Centre

Pune, Maharashtra, 411 011, India

Location

Bharati Vidyapeeth University Medical College

Pune, Maharashtra, 411043, India

Location

Sri Ramachandra Hospital

Chennai, Tamil Nadu, 600116, India

Location

Kanchi Kamakoti Childs Trust Hospital

Chennai, Tamil Nadu, 600034, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

Related Publications (1)

• 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.

  PMID: 34656378 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 7, 2018
• Study Start: May 31, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: September 30, 2020
• Results First Posted: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

IN (7)