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
CompletedPhase 4Results postedLast updated 30 September 2020
What this trial tests
Phase 4 trial testing 13vPnC in Vaccines in 301 participants. Completed in 20 December 2019.
Adults 42 Days to 72 Days, any sex, with Vaccines. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1Primary· 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
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1Primary· 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
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2Primary· 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 thes
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2Primary· 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 inte
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3Primary· 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 thes
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3Primary· 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 inte
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4Primary· 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 thes
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4Primary· 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 inte
Percentage of Participants With Adverse Events (AEs) After Vaccination 1 up to 1 Month After Vaccination 3Primary· From Vaccination 1 up to 1 Month after Vaccination 3 (for a maximum study duration of 3 months)
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship.
Percentage of Participants With Adverse Events (AEs) From Vaccination 4 up to 1 Month After Vaccination 4Primary· From Vaccination 4 up to 1 month after Vaccination 4 (for a maximum study duration of 1 month)
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship.
Percentage of Participants With Serious Adverse Events (SAEs) After Vaccination 1 up to 1 Month After Vaccination 4Primary· From Vaccination 1 up to 1 month after Vaccination 4 (for a maximum study duration of 11.5 months)
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.
Number of Participants With New Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Vaccination 3 up to Vaccination 4Primary· From 1 month after Vaccination 3 up to Vaccination 4 (for a maximum study duration of 7.5 months)
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.
Time frame: Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
13vPnC, MDV With Preservative: Infant Series
Serious: 5/150 (3%)
Deaths: 0/150
13vPnC, PFS Without Preservative: Infant Series
Serious: 4/150 (3%)
Deaths: 0/150
13vPnC, MDV: Between Infant Series and Toddler Dose
Serious: 6/150 (4%)
Deaths: 0/150
13vPnC, PFS: Between Infant Series and Toddler Dose
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT07019909 — A Study to Learn About How Safe and Effective is 20vPnC and 13vPnC Vaccines in Chinese Adults
· Phase 1
· completed
NCT07023081 — A Study to Understand the Safety of the 20vPnC Vaccine in Healthy Chinese Adults, Children, and Infant
· Phase 1
· active not recruiting
NCT05489328 — Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age
· Phase 1
· completed
NCT04875533 — 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years o
· Phase 3
· completed
NCT03828617 — Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Va
· Phase 3
· completed
Other recruiting trials for Vaccines
Currently open trials in the same condition.
NCT05032976 — Korea Comirnaty Post-marketing Surveillance
· active not recruiting
Other Pfizer trials
Trials by the same sponsor.
NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna®
· not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market
· not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea
· not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta
· Phase 1
· not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 30 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03548337.