Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)

NCT ID: NCT03848065

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2020-06-24

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).

Conditions

Pneumococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

V114-SC

Infant participants will receive a single 0.5 mL subcutaneous (SC) injection of V114 on Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age). Infant participants will receive a single 0.5 mL SC injection of concomitant study vaccine \[Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV) at the same time as V114-SC.

Group Type: EXPERIMENTAL

V114

Intervention Type: BIOLOGICAL

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)

Intervention Type: BIOLOGICAL

Single SC dose of 0.5 mL at Visits 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).

V114-IM

Infant participants will receive a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age). Infant participants will receive a single 0.5 mL SC injection of concomitant study vaccine (DTaP-IPV) at the same time as V114-IM.

Group Type: EXPERIMENTAL

V114

Intervention Type: BIOLOGICAL

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)

Intervention Type: BIOLOGICAL

Single SC dose of 0.5 mL at Visits 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).

PCV13-SC

Infant participants will receive a single 0.5 mL subcutaneous (SC) injection of pneumococcal 13-valent conjugate vaccine (PCV13) at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age). Infant participants will receive a single 0.5 mL SC injection of concomitant study vaccine (DTaP-IPV) at the same time as PCV13-SC.

Group Type: ACTIVE_COMPARATOR

Pneumococcal 13-valent Conjugate Vaccine (PCV13)

Intervention Type: BIOLOGICAL

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.

Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)

Intervention Type: BIOLOGICAL

Single SC dose of 0.5 mL at Visits 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).

Interventions

V114

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

Intervention Type: BIOLOGICAL

Pneumococcal 13-valent Conjugate Vaccine (PCV13)

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.

Intervention Type: BIOLOGICAL

Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)

Single SC dose of 0.5 mL at Visits 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).

Intervention Type: BIOLOGICAL

Other Intervention Names

VAXNEUVANCE™; Pneumococcal 15-Valent Conjugate Vaccine; PREVNAR 13®

Eligibility Criteria

Inclusion Criteria

• Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator.
• Male or female 3 months of age inclusive (3 months of age to1 day prior to 4 months of age), at the time of obtaining the informed consent.
• Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

Exclusion Criteria

• Has a history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
• Has a known hypersensitivity to vaccines, any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
• Has any contraindication to the PCV13 and/or diphtheria, tetanus, acellular pertussis, inactivated polio vaccine (DTaP-IPV) being administered in the study (Refer to approved labeling for contraindication details on PCV13 and DTaPIPV vaccine).
• Has a recent febrile illness (axillary temperature ≥37.5°C) occurring within 72 hours prior to receipt of study vaccine.
• Has a known or suspected impairment of immunological function.
• Has a history of congenital or acquired immunodeficiency.
• Has or his/her mother has a documented hepatitis B surface antigen - positive test.
• Has a known functional or anatomic asplenia.
• Has failure to thrive based on the clinical judgement of the investigator.
• Has thrombocytopenia or a known coagulation disorder contraindicating intramuscular vaccination.
• Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Bechet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders).
• Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
• Has received a dose of any pneumococcal and/or DTaP-IPV vaccine (or vaccine containing any DTaP-IPV component) prior to study entry.
• Has received other licensed non-live vaccines within the 14 days before receipt of first dose of study vaccine.
• Has received a licensed live virus vaccine within the 28 days before receipt of first dose of study vaccine.
• Has received a blood transfusion or blood products, including immunoglobulins before receipt of first dose of study vaccine.
• Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case by case basis for approval by the Sponsor.
• Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study. (Refer to the Vaccination Guideline in Japan). Reasons may include, but are not limited to, being unable to keep appointments or planning to relocate during the study.
• Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Meitetsu Hospital ( Site 2805)

Nagoya, Aichi-ken, Japan

Sotobo Children's Clinic ( Site 2807)

Isumi, Chiba, Japan

Hidaka Children's Clinic ( Site 2803)

Dazaifu, Fukuoka, Japan

Isesaki Municipal Hospital ( Site 2806)

Isesaki, Gunma, Japan

Kawasaki Municipal Hospital ( Site 2802)

Kawasaki, Kanagawa, Japan

Yokosuka Kyosai Hospital ( Site 2804)

Yokosuka, Kanagawa, Japan

Suita Municipal Hospital ( Site 2801)

Suita, Osaka, Japan

Kobayashi Pediatric Clinic ( Site 2816)

Fujieda, Shizuoka, Japan

Nishida Kodomo Clinic ( Site 2811)

Tama, Tokyo, Japan

Fukui Aiiku Hospital ( Site 2809)

Fukui, , Japan

Fukui-ken Saiseikai Hospital ( Site 2813)

Fukui, , Japan

Kubota Children's Clinic ( Site 2815)

Osaka, , Japan

Japanese Red Cross Shizuoka Hospital ( Site 2817)

Shizuoka, , Japan

Hosaka Children's Clinic ( Site 2814)

Tokyo, , Japan

Countries

Japan

References

Ishihara Y, Kuroki H, Hidaka H, Iwai K, Wan K, Shirakawa M, Sawata M. Safety and immunogenicity of a 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A Phase I study (V114-028). Hum Vaccin Immunother. 2023 Dec 31;19(1):2180973. doi: 10.1080/21645515.2023.2180973. Epub 2023 Mar 7.

Reference Type: RESULT

PMID: 36882898 (View on PubMed)

Wan K, Shirakawa M, Sawata M. Descriptive analysis of safety and immunogenicity profiles of a 15-valent pneumococcal conjugate vaccine between subcutaneous and intramuscular administration in a phase 1 study of healthy Japanese infants (V114-028). J Infect Chemother. 2025 Feb;31(2):102539. doi: 10.1016/j.jiac.2024.10.007. Epub 2024 Oct 9.

Reference Type: RESULT

PMID: 39384037 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

194669

Identifier Type: REGISTRY

Identifier Source: secondary_id

V114-028

Identifier Type: -

Identifier Source: org_study_id