20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT04530838

Collaborator

(none)

668

Enrollment

Locations

Arms

18.5

Actual Duration (Months)

17.1

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Disease	Biological: 20-valent pneumococcal conjugate vaccine Biological: 13-valent pneumococcal conjugate vaccine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

668 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY UNBLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY JAPANESE INFANTS

Actual Study Start Date :

Sep 16, 2020

Actual Primary Completion Date :

Apr 2, 2022

Actual Study Completion Date :

Apr 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 20-valent pneumococcal conjugate vaccine (subcutaneous) 20-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)	Biological: 20-valent pneumococcal conjugate vaccine 20-valent pneumococcal conjugate vaccine
Active Comparator: 13-valent pneumococcal conjugate vaccine (subcutaneous) 13-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)	Biological: 13-valent pneumococcal conjugate vaccine 13-valent pneumococcal conjugate vaccine
Experimental: 20-valent pneumococcal conjugate vaccine (intramuscular) 20-valent pneumococcal conjugate vaccine administered by intramuscular injection (IM)	Biological: 20-valent pneumococcal conjugate vaccine 20-valent pneumococcal conjugate vaccine

Arm

Intervention/Treatment

Experimental: 20-valent pneumococcal conjugate vaccine (subcutaneous)

20-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)

Biological: 20-valent pneumococcal conjugate vaccine

20-valent pneumococcal conjugate vaccine

Active Comparator: 13-valent pneumococcal conjugate vaccine (subcutaneous)

13-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)

Biological: 13-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

Experimental: 20-valent pneumococcal conjugate vaccine (intramuscular)

20-valent pneumococcal conjugate vaccine administered by intramuscular injection (IM)

Biological: 20-valent pneumococcal conjugate vaccine

20-valent pneumococcal conjugate vaccine

Outcome Measures

Primary Outcome Measures

The percentages of participants reporting prompted local reactions within 7 days after each vaccination in each group [7 days]
Prompted local reactions after each dose
The percentages of participants reporting prompted systemic events within 7 days after each vaccination in each group [7 days]
Prompted systemic events after each dose
The percentages of participants reporting AEs from Dose 1 to 1 month after Dose 3 in each group [Dose 1 to 1 month after Dose 3]
Adverse events occurring from Dose 1 to 1 month after Dose 3
The percentages of participants reporting AEs from Dose 4 to 1 month after Dose 4 in each group [Dose 4 to 1 month after Dose 4]
Adverse events occurring from Dose 4 to 1 month after Dose 4
The percentages of participants reporting SAEs up to 1 month after Dose 4 in each group [Dose 1 to 1 month after Dose 4]
SAEs occurring up to 1 month after Dose 4
The percentages of participants reporting NDCMCs up to 1 month after Dose 4 in each group [Dose 1 to 1 month after Dose 4]
NDCMCs occurring up to 1 month after Dose 4
The percentages of participants with pre-defined pneumococcal IgG concentrations at 1 month after Dose 3 [1 month after Dose 3]
IgG concentrations 1 month after Dose 3

Secondary Outcome Measures

IgG GMCs 1 month after Dose 3 [1 month after Dose 3]
IgG GMCs 1 month after Dose 3
The percentages of participants with pre-defined pneumococcal IgG concentrations at 1 month after Dose 4 [1 month after Dose 4]
IgG concentrations 1 month after Dose 4
IgG GMCs 1 month after Dose 4 [1 month after Dose 4]
IgG GMCs 1 month after Dose 4
OPA GMTs 1 month after Dose 3 [1 month after Dose 3]
OPA GMTs 1 month after Dose 3
OPA GMTs 1 month after Dose 4 [1 month after Dose 4]
OPA GMTs 1 month after Dose 4
IgG GMFRs from 1 month after Dose 3 to before Dose 4 [From 1 month after Dose 3 to before Dose 4]
IgG GMFRs from 1 month after Dose 3 to before Dose 4
IgG GMFRs from before Dose 4 to 1 month after Dose 4 [From before Dose 4 to 1 month after Dose 4]
IgG GMFRs from before Dose 4 to 1 month after Dose 4
IgG GMFRs from 1 month after Dose 3 to 1 month after Dose 4 [From 1 month after Dose 3 to 1 month after Dose 4]
IgG GMFRs from 1 month after Dose 3 to 1 month after Dose 4

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 6 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Japanese male or female infants ≥2 months to ≤6 months at the time of consent.
Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
Major known congenital malformation or serious chronic disorder.
History of microbiologically proven invasive disease caused by S pneumoniae.
Other acute or chronic medical or psychiatric condition or 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 participant inappropriate for entry into this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NHO Nagoya Medical Center	Nagoya-shi	Aichi	Japan	460-0001
2	TOYOTA Memorial Hospital	Toyota-shi	Aichi	Japan	471-8513
3	Tsubaki Children's Clinic	Chiba-shi	Chiba	Japan	260-0001
4	Sunrise Children's Clinic	Funabashi-city	Chiba	Japan	273-0035
5	medical corporation Shigyo-no-kai Sotobo Children's Clinic	Isumi-city	Chiba	Japan	299-4503
6	Sou Clinic	Yotsukaido-shi	Chiba	Japan	284-0001
7	NHO Shimoshizu National Hospital	Yotsukaido-shi	Chiba	Japan	284-0003
8	Fukui Aiiku Hospital	Fukui-shi	Fukui	Japan	910-0833
9	Fukazawa Clinic	Fukuoka-City	Fukuoka	Japan	813-0036
10	Shindo children's clinic	Fukuoka-city	Fukuoka	Japan	814-0121
11	Inamitsu Children's Clinic	Fukuoka-city	Fukuoka	Japan	819-0041
12	Shimomura Pediatrics Clinic	Fukuoka-shi	Fukuoka	Japan	819-0002
13	Iizuka Hospital	Iizuka	Fukuoka	Japan	820-8505
14	Yokoyama Children'S Clinic	Kasuga-city	Fukuoka	Japan	816-0801
15	Yajima Children's Clinic	Gifu-city	Gifu	Japan	500-8212
16	Azuma kodomo katei clinic	Ebetsu Shi	Hokkaido	Japan	069-0816
17	Nishi Sapporo Pediatrics	Sapporo shi	Hokkaido	Japan	0630061
18	Nakata pediatric clinic	Sapporo	Hokkaido	Japan	003-0023
19	Yoshimura Child Clinic	Akashi-City	Hyōgo	Japan	674-0068
20	Morino Kodomo Clinic	Kawasaki-shi	Kanagawa	Japan	211-0063
21	MIURA Children's Clinic	Kumamoto Shi	Kumamoto	Japan	862-0960
22	Sakuranbo Kodomo Clinic	Kumamoto-shi	Kumamoto	Japan	862-0924
23	Matsuda Pediatric Clinic	Kuwana-city	MIE	Japan	511-0865
24	Arakawa Children's Clinic	Nagano-shi	Nagano	Japan	381-0025
25	Arakawa Family Clinic	Nagano-shi	Nagano	Japan	381-0025
26	NHO Osaka Minami Medical Center	Kawachinagano	Osaka	Japan	586-8521
27	Aizenbashi Hospital	Osaka-City	Osaka	Japan	556-0005
28	NHO Ureshino Medical center	Ureshino-shi	Saga	Japan	843-0393
29	Hanyu General Hospital	Hanyu-shi	Saitama	Japan	348-0045
30	Enomoto Clinic	Kumagaya-shi	Saitama	Japan	360-0018
31	Saiseikai Shiga Hospital	Ritto-Shi	Shiga	Japan	520-3046
32	Sakiyama Pediatric Clinic	Fuchu-city	Tokyo	Japan	183-0042
33	Saitoh-Clinic	Nishitokyo-shi	Tokyo	Japan	202-0004
34	Inami Pediatrics	Setagaya-ku	Tokyo	Japan	154-0002
35	Sasamoto Children's Clinic	Setagaya-ku	Tokyo	Japan	157-0066
36	Futaba Clinic	Shinjuku-ku	Tokyo	Japan	160-0017
37	Tamura Clinic	Suginami-ku	Tokyo	Japan	167-0052
38	Childrens clinic of Kose	Kofu-city	Yamanashi	Japan	400-0853
39	Takei Clinic	Tsuru-shi	Yamanashi	Japan	402-0025

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT04530838

Other Study ID Numbers:

B7471016
2022-001146-38

First Posted:

Aug 28, 2020

Last Update Posted:

Apr 18, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Pneumococcal Infections

Vaccines

Heptavalent Pneumococcal Conjugate Vaccine

Study Results

No Results Posted as of Apr 18, 2022