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

A Phase I, Double-Blind, Randomized, Multicenter Trial of the Safety,Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03848065

Enrollment

133

Registered

2019-02-20

Start date

2019-04-02

Completion date

2020-06-24

Last updated

2025-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infections

Keywords

Pneumococcal Vaccines

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).

Interventions

BIOLOGICALV114

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.

BIOLOGICALPneumococcal 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.

BIOLOGICALAdsorbed 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

3 Months to 3 Months

Healthy volunteers

Yes

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. * Meets one or more of the following systemic corticosteroid

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Day 1 to Day 14 post each vaccination	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs were injection site erythema (redness), injection site induration (hard lump), injection site pain and injection site swelling.
Percentage of Participants With a Solicited Systemic Adverse Event	Day 1 to Day 14 post each vaccination	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs were decreased appetite (appetite loss), somnolence (drowsiness), irritability and urticaria (hives/welts).
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)	Up to 4 weeks post vaccination 4 (~14.5 months)	An SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator.

Secondary

Measure	Time frame	Description
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	One month post vaccination 3 (~3 months after Vaccination 1)	Serotype-specific pneumococcal IgG antibody was measured using pneumococcal electrochemiluminescence (PnECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.
Serotype-specific IgG Geometric Mean Concentrations (GMCs)	1 month post vaccination 3 (~3 months after Vaccination 1)	The anti-pneumococcal polysaccharide (PnPs) serotype-specific IgG Geometric Mean Concentrations (GMCs) were determined using an electrochemiluminescence assay.
Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	1 month post vaccination 3 (~3 months after Vaccination 1)	DTaP-IPV antibody titers were measured by neutralization assay (diphtheria toxin and poliovirus 1/2/3), particle agglutination assay (tetanus toxin) and enzyme-linked immunosorbent assay (ELISA) methodology (pertussis PT and pertussis FHA) 1 month post vaccination 3. Threshold values were: Diphtheria toxin level ≥0.1 IU/mL, Pertussis PT level ≥10 EU/mL, Pertussis FHA level ≥10 EU/mL, Tetanus toxin level ≥0.01 IU/mL, Neutralizing antibody (NA) titers of Polio virus types 1/2/3 ≥1:8.

Countries

Japan

Participant flow

Recruitment details

Healthy male and female participants of 3 months of age were enrolled in this study.

Participants by arm

Arm	Count
V114-SC Infant participants received a single 0.5 mL SC injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).	44
V114-IM Infant participants received a single 0.5 mL IM injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).	45
PCV13-SC Infant participants received a single 0.5 mL SC injection of PCV13 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).	44
Total	133

Withdrawals & dropouts

Period	Reason	FG001	FG002
Overall Study	Death	1	0
Overall Study	Lost to Follow-up	0	1
Overall Study	Physician Decision	0	1

Baseline characteristics

Characteristic	V114-SC	V114-IM	PCV13-SC	Total
Age, Continuous	13.7 Weeks STANDARD_DEVIATION 0.8	13.9 Weeks STANDARD_DEVIATION 1	13.8 Weeks STANDARD_DEVIATION 1.1	13.8 Weeks STANDARD_DEVIATION 1
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants	45 Participants	44 Participants	133 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	44 Participants	45 Participants	44 Participants	133 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	20 Participants	18 Participants	20 Participants	58 Participants
Sex: Female, Male Male	24 Participants	27 Participants	24 Participants	75 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 44	1 / 45	0 / 44
other Total, other adverse events	44 / 44	44 / 45	43 / 43
serious Total, serious adverse events	1 / 44	3 / 45	2 / 43

Outcome results

Primary

Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs were injection site erythema (redness), injection site induration (hard lump), injection site pain and injection site swelling.

Time frame: Day 1 to Day 14 post each vaccination

Population: Analysis population consisted of all randomized participants who received at least one dose of trial vaccine.

Arm	Measure	Group	Value (NUMBER)
V114-SC	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Injection Site Erythema (Redness)	100.0 Percentage of Participants
V114-SC	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Injection Site Induration (Hard Lump)	90.9 Percentage of Participants
V114-SC	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Injection Site Pain	38.6 Percentage of Participants
V114-SC	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Injection Site Swelling	86.4 Percentage of Participants
V114-IM	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Injection Site Swelling	73.3 Percentage of Participants
V114-IM	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Injection Site Erythema (Redness)	82.2 Percentage of Participants
V114-IM	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Injection Site Pain	28.9 Percentage of Participants
V114-IM	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Injection Site Induration (Hard Lump)	77.8 Percentage of Participants
PCV13-SC	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Injection Site Swelling	88.4 Percentage of Participants
PCV13-SC	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Injection Site Induration (Hard Lump)	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Injection Site Pain	41.9 Percentage of Participants
PCV13-SC	Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	Injection Site Erythema (Redness)	95.3 Percentage of Participants

Comparison: Injection Site Erythema (Redness)p-value: 0.00495% CI: [9, 31.4]Miettinen & Nurminen method

Comparison: Injection Site Erythema (Redness)p-value: 0.1595% CI: [-3.7, 15.5]Miettinen & Nurminen method

Comparison: Injection Site Erythema (Redness)p-value: 0.05495% CI: [-27.6, 0.2]Miettinen & Nurminen method

Comparison: Injection Site Induration (Hard Lump)p-value: 0.09195% CI: [-2.3, 28.8]Miettinen & Nurminen method

Comparison: Injection Site Induration (Hard Lump)p-value: 0.04495% CI: [-21.2, -0.4]Miettinen & Nurminen method

Comparison: Injection Site Induration (Hard Lump)p-value: 0.00195% CI: [-36.4, -12.5]Miettinen & Nurminen method

Comparison: Injection Site Painp-value: 0.33395% CI: [-10, 28.9]Miettinen & Nurminen method

Comparison: Injection Site Painp-value: 0.7695% CI: [-23.4, 17.2]Miettinen & Nurminen method

Comparison: Injection Site Painp-value: 0.20595% CI: [-32.2, 7.1]Miettinen & Nurminen method

Comparison: Injection Site Swellingp-value: 0.12895% CI: [-3.9, 29.7]Miettinen & Nurminen method

Comparison: Injection Site Swellingp-value: 0.77995% CI: [-17, 13]Miettinen & Nurminen method

Comparison: Injection Site Swellingp-value: 0.07695% CI: [-31.5, 1.7]Miettinen & Nurminen method

Primary

Percentage of Participants With a Solicited Systemic Adverse Event

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs were decreased appetite (appetite loss), somnolence (drowsiness), irritability and urticaria (hives/welts).

Time frame: Day 1 to Day 14 post each vaccination

Population: Analysis population consisted of all randomized participants who received at least one dose of trial vaccine.

Arm	Measure	Group	Value (NUMBER)
V114-SC	Percentage of Participants With a Solicited Systemic Adverse Event	Decreased Appetite (Appetite Loss)	25.0 Percentage of Participants
V114-SC	Percentage of Participants With a Solicited Systemic Adverse Event	Somnolence (Drowsiness)	70.5 Percentage of Participants
V114-SC	Percentage of Participants With a Solicited Systemic Adverse Event	Irritability	81.8 Percentage of Participants
V114-SC	Percentage of Participants With a Solicited Systemic Adverse Event	Urticaria (Hives/Welts)	9.1 Percentage of Participants
V114-IM	Percentage of Participants With a Solicited Systemic Adverse Event	Urticaria (Hives/Welts)	4.4 Percentage of Participants
V114-IM	Percentage of Participants With a Solicited Systemic Adverse Event	Decreased Appetite (Appetite Loss)	35.6 Percentage of Participants
V114-IM	Percentage of Participants With a Solicited Systemic Adverse Event	Irritability	71.1 Percentage of Participants
V114-IM	Percentage of Participants With a Solicited Systemic Adverse Event	Somnolence (Drowsiness)	60.0 Percentage of Participants
PCV13-SC	Percentage of Participants With a Solicited Systemic Adverse Event	Urticaria (Hives/Welts)	7.0 Percentage of Participants
PCV13-SC	Percentage of Participants With a Solicited Systemic Adverse Event	Somnolence (Drowsiness)	74.4 Percentage of Participants
PCV13-SC	Percentage of Participants With a Solicited Systemic Adverse Event	Irritability	74.4 Percentage of Participants
PCV13-SC	Percentage of Participants With a Solicited Systemic Adverse Event	Decreased Appetite (Appetite Loss)	34.9 Percentage of Participants

Comparison: Decreased Appetite (Appetite Loss)p-value: 0.28295% CI: [-29.1, 8.7]Miettinen & Nurminen method

Comparison: Decreased Appetite (Appetite Loss)p-value: 0.31795% CI: [-28.7, 9.5]Miettinen & Nurminen method

Comparison: Decreased Appetite (Appetite Loss)p-value: 0.94895% CI: [-19.2, 20.4]Miettinen & Nurminen method

Comparison: Somnolence (Drowsiness)p-value: 0.30395% CI: [-9.4, 29.6]Miettinen & Nurminen method

Comparison: Somnolence (Drowsiness)p-value: 0.68195% CI: [-22.6, 15]Miettinen & Nurminen method

Comparison: Somnolence (Drowsiness)p-value: 0.15395% CI: [-33.2, 5.4]Miettinen & Nurminen method

Comparison: Irritabilityp-value: 0.23795% CI: [-7.2, 28.2]Miettinen & Nurminen method

Comparison: Irritabilityp-value: 0.40695% CI: [-10.3, 25]Miettinen & Nurminen method

Comparison: Irritabilityp-value: 0.72995% CI: [-21.8, 15.5]Miettinen & Nurminen method

Comparison: Urticaria (Hives/Welts)p-value: 0.38595% CI: [-7.1, 17.5]Miettinen & Nurminen method

Comparison: Urticaria (Hives/Welts)p-value: 0.71995% CI: [-11, 15.4]Miettinen & Nurminen method

Comparison: Urticaria (Hives/Welts)p-value: 0.6195% CI: [-14.9, 8.9]Miettinen & Nurminen method

Primary

Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)

An SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator.

Time frame: Up to 4 weeks post vaccination 4 (~14.5 months)

Population: Analysis population consisted of all randomized participants who received at least one dose of trial vaccine.

Arm	Measure	Value (NUMBER)
V114-SC	Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)	0.0 Percentage of Participants
V114-IM	Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)	0.0 Percentage of Participants
PCV13-SC	Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)	0.0 Percentage of Participants

Secondary

Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL

Serotype-specific pneumococcal IgG antibody was measured using pneumococcal electrochemiluminescence (PnECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.

Time frame: One month post vaccination 3 (~3 months after Vaccination 1)

Population: Analysis population consisted of those participants who were not considered protocol violators.

Arm	Measure	Group	Value (NUMBER)
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 6B	90.9 Percentage of Participants
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 4	100.0 Percentage of Participants
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 19A	100.0 Percentage of Participants
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 7F	100.0 Percentage of Participants
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 3	100.0 Percentage of Participants
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 18C	100.0 Percentage of Participants
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 9V	100.0 Percentage of Participants
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 23F	97.7 Percentage of Participants
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 14	97.7 Percentage of Participants
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 5	100.0 Percentage of Participants
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 33F	81.8 Percentage of Participants
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	Serotype (ST) 1	100.0 Percentage of Participants
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 6A	97.7 Percentage of Participants
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 22F	95.5 Percentage of Participants
V114-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 19F	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 19F	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	Serotype (ST) 1	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 3	97.8 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 4	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 5	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 6A	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 6B	93.3 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 7F	97.8 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 9V	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 14	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 18C	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 19A	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 23F	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 22F	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 33F	88.9 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 6B	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 22F	4.8 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 19A	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 6A	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 5	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 19F	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 4	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	Serotype (ST) 1	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 23F	97.6 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 9V	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 3	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 14	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 7F	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 33F	0.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL	ST 18C	100.0 Percentage of Participants

Comparison: ST 195% CI: [-8.1, 8.5]

Comparison: ST 195% CI: [-7.9, 8.5]

Comparison: ST 195% CI: [-8.1, 7.9]

Comparison: ST 395% CI: [-8.1, 8.5]

Comparison: ST 395% CI: [-11.7, 6.3]

Comparison: ST 395% CI: [-6, 11.6]

Comparison: ST 495% CI: [-8.1, 8.5]

Comparison: ST 495% CI: [-7.9, 8.5]

Comparison: ST 495% CI: [-8.1, 7.9]

Comparison: ST 595% CI: [-8.1, 8.5]

Comparison: ST 595% CI: [-7.9, 8.5]

Comparison: ST 595% CI: [-8.1, 7.9]

Comparison: ST 6A95% CI: [-11.9, 6.3]

Comparison: ST 6A95% CI: [-7.9, 8.5]

Comparison: ST 6A95% CI: [-11.9, 5.8]

Comparison: ST 6B95% CI: [-21.2, -0.2]

Comparison: ST 6B95% CI: [-17.9, 2.1]

Comparison: ST 6B95% CI: [-15.6, 10.2]

Comparison: ST 7F95% CI: [-8.1, 8.5]

Comparison: ST 7F95% CI: [-11.7, 6.3]

Comparison: ST 7F95% CI: [-6, 11.6]

Comparison: ST 9V95% CI: [-8.1, 8.5]

Comparison: ST 9V95% CI: [-7.9, 8.5]

Comparison: ST 9V95% CI: [-8.1, 7.9]

Comparison: ST 1495% CI: [-11.9, 6.3]

Comparison: ST 1495% CI: [-7.9, 8.5]

Comparison: ST 1495% CI: [-11.9, 5.8]

Comparison: ST 18C95% CI: [-8.1, 8.5]

Comparison: ST 18C95% CI: [-7.9, 8.5]

Comparison: ST 18C95% CI: [-8.1, 7.9]

Comparison: ST 19A95% CI: [-8.1, 8.5]

Comparison: ST 19A95% CI: [-7.9, 8.5]

Comparison: ST 19A95% CI: [-8.1, 7.9]

Comparison: ST 19F95% CI: [-8.1, 8.5]

Comparison: ST 19F95% CI: [-7.9, 8.5]

Comparison: ST 19F95% CI: [-8.1, 7.9]

Comparison: ST 23F95% CI: [-9.8, 10.4]

Comparison: ST 23F95% CI: [-5.7, 12.4]

Comparison: ST 23F95% CI: [-11.9, 5.8]

Comparison: ST 22F95% CI: [77.2, 96.4]

Comparison: ST 22F95% CI: [84.1, 98.7]

Comparison: ST 22F95% CI: [-15.2, 3.6]

Comparison: ST 33F95% CI: [67.9, 90.5]

Comparison: ST 33F95% CI: [76.4, 95.2]

Comparison: ST 33F95% CI: [-22.7, 8.2]

Secondary

Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)

DTaP-IPV antibody titers were measured by neutralization assay (diphtheria toxin and poliovirus 1/2/3), particle agglutination assay (tetanus toxin) and enzyme-linked immunosorbent assay (ELISA) methodology (pertussis PT and pertussis FHA) 1 month post vaccination 3. Threshold values were: Diphtheria toxin level ≥0.1 IU/mL, Pertussis PT level ≥10 EU/mL, Pertussis FHA level ≥10 EU/mL, Tetanus toxin level ≥0.01 IU/mL, Neutralizing antibody (NA) titers of Polio virus types 1/2/3 ≥1:8.

Time frame: 1 month post vaccination 3 (~3 months after Vaccination 1)

Population: Analysis population consisted of those participants who were not considered protocol violators.

Arm	Measure	Group	Value (NUMBER)
V114-SC	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Tetanus toxin	100.0 Percentage of Participants
V114-SC	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Poliovirus Type 1	100.0 Percentage of Participants
V114-SC	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Pertussis FHA	100.0 Percentage of Participants
V114-SC	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Diphtheria toxin	97.7 Percentage of Participants
V114-SC	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Poliovirus Type 3	100.0 Percentage of Participants
V114-SC	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Poliovirus Type 2	100.0 Percentage of Participants
V114-SC	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Pertussis toxin	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Pertussis FHA	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Diphtheria toxin	95.6 Percentage of Participants
V114-IM	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Tetanus toxin	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Pertussis toxin	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Poliovirus Type 1	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Poliovirus Type 2	100.0 Percentage of Participants
V114-IM	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Poliovirus Type 3	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Poliovirus Type 1	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Tetanus toxin	97.6 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Poliovirus Type 3	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Poliovirus Type 2	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Pertussis FHA	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Pertussis toxin	100.0 Percentage of Participants
PCV13-SC	Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)	Diphtheria toxin	95.2 Percentage of Participants

Comparison: Diphtheria Toxin95% CI: [-7.7, 13.9]

Comparison: Diphtheria Toxin95% CI: [-10.8, 12]

Comparison: Diphtheria Toxin95% CI: [-8, 13]

Comparison: Tetanus Toxin95% CI: [-5.8, 12.4]

Comparison: Tetanus Toxin95% CI: [-5.7, 12.4]

Comparison: Tetanus Toxin95% CI: [-8.1, 7.9]

Comparison: Pertussis Toxin95% CI: [-8.1, 8.5]

Comparison: Pertussis Toxin95% CI: [-7.9, 8.5]

Comparison: Pertussis Toxin95% CI: [-8.1, 7.9]

Comparison: Pertussis FHA95% CI: [-8.1, 8.5]

Comparison: Pertussis FHA95% CI: [-7.9, 8.5]

Comparison: Pertussis FHA95% CI: [-8.1, 7.9]

Comparison: Poliovirus Type 195% CI: [-8.1, 8.5]

Comparison: Poliovirus Type 195% CI: [-7.9, 8.5]

Comparison: Poliovirus Type 195% CI: [-8.1, 7.9]

Comparison: Poliovirus Type 295% CI: [-8.1, 8.5]

Comparison: Poliovirus Type 295% CI: [-7.9, 8.5]

Comparison: Poliovirus Type 295% CI: [-8.1, 7.9]

Comparison: Poliovirus Type 395% CI: [-8.1, 8.5]

Comparison: Poliovirus Type 395% CI: [-7.9, 8.5]

Comparison: Poliovirus Type 395% CI: [-8.1, 7.9]

Secondary

Serotype-specific IgG Geometric Mean Concentrations (GMCs)

The anti-pneumococcal polysaccharide (PnPs) serotype-specific IgG Geometric Mean Concentrations (GMCs) were determined using an electrochemiluminescence assay.

Time frame: 1 month post vaccination 3 (~3 months after Vaccination 1)

Population: Analysis population consisted of those participants who were not considered protocol violators.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 6B	1.51 μg/mL
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 4	5.40 μg/mL
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 19A	6.27 μg/mL
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 7F	2.95 μg/mL
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 3	3.95 μg/mL
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 18C	3.10 μg/mL
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 9V	4.18 μg/mL
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 23F	2.56 μg/mL
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 14	11.43 μg/mL
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 5	3.51 μg/mL
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 33F	1.15 μg/mL
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 1	4.03 μg/mL
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 6A	2.09 μg/mL
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 22F	6.82 μg/mL
V114-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 19F	5.42 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 19F	5.85 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 1	4.55 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 3	4.52 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 4	6.02 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 5	3.98 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 6A	2.30 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 6B	1.72 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 7F	3.32 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 9V	4.75 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 14	13.79 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 18C	3.17 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 19A	5.25 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 23F	2.57 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 22F	10.35 μg/mL
V114-IM	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 33F	1.56 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 6B	2.85 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 22F	0.05 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 19A	7.22 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 6A	3.33 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 5	4.20 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 19F	7.62 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 4	7.48 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 1	5.30 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 23F	3.24 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 9V	5.54 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 3	3.04 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 14	13.54 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 7F	4.85 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 33F	0.05 μg/mL
PCV13-SC	Serotype-specific IgG Geometric Mean Concentrations (GMCs)	ST 18C	4.48 μg/mL

Comparison: ST 195% CI: [0.58, 1]

95% CI: [0.65, 1.13]

95% CI: [0.68, 1.16]

Comparison: ST 395% CI: [0.96, 1.76]

Comparison: ST 395% CI: [1.1, 2.01]

Comparison: ST 395% CI: [0.65, 1.18]

Comparison: ST 495% CI: [0.58, 0.9]

Comparison: ST 495% CI: [0.65, 1]

Comparison: ST 495% CI: [0.72, 1.11]

Comparison: ST 595% CI: [0.6, 1.16]

Comparison: ST 595% CI: [0.69, 1.31]

Comparison: ST 595% CI: [0.64, 1.21]

Comparison: ST 6A95% CI: [0.47, 0.84]

Comparison: ST 6A95% CI: [0.52, 0.93]

Comparison: ST 6A95% CI: [0.68, 1.21]

Comparison: ST 6B95% CI: [0.36, 0.79]

Comparison: ST 6B95% CI: [0.41, 0.9]

Comparison: ST 6B95% CI: [0.59, 1.3]

Comparison: ST 7F95% CI: [0.46, 0.81]

Comparison: ST 7F95% CI: [0.52, 0.9]

Comparison: ST 7F95% CI: [0.67, 1.17]

Comparison: ST 9V95% CI: [0.57, 0.99]

Comparison: ST 9V95% CI: [0.65, 1.13]

Comparison: ST 9V95% CI: [0.67, 1.15]

Comparison: ST 1495% CI: [0.6, 1.19]

Comparison: ST 1495% CI: [0.72, 1.43]

Comparison: ST 1495% CI: [0.59, 1.16]

Comparison: ST 18C95% CI: [0.53, 0.9]

Comparison: ST 18C95% CI: [0.54, 0.92]

Comparison: ST 18C95% CI: [0.76, 1.27]

Comparison: ST 19A95% CI: [0.66, 1.15]

Comparison: ST 19A95% CI: [0.55, 0.96]

Comparison: ST 19A95% CI: [0.9, 1.57]

Comparison: ST 19F95% CI: [0.57, 0.89]

Comparison: ST 19F95% CI: [0.62, 0.95]

Comparison: ST 19F95% CI: [0.75, 1.15]

Comparison: ST 23F95% CI: [0.57, 1.09]

Comparison: ST 23F95% CI: [0.58, 1.09]

Comparison: ST 23F95% CI: [0.73, 1.36]

Comparison: ST 22F95% CI: [88.91, 204.62]

Comparison: ST 22F95% CI: [135.18, 309.69]

Comparison: ST 22F95% CI: [0.44, 0.99]

Comparison: ST 33F95% CI: [15.34, 41.13]

Comparison: ST 33F95% CI: [20.93, 55.83]

Comparison: ST 33F95% CI: [0.45, 1.19]

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

Percentage of Participants With a Solicited Systemic Adverse Event

Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)

Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL

Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)

Serotype-specific IgG Geometric Mean Concentrations (GMCs)