Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)

A Phase III Open-label Randomised Study, to Evaluate the Immunogenicity and Safety of the Concomitant Administration of V419 (PR5I) Given at 2, 3 and 4 Months of Age With Two Types of Meningococcal Serogroup C Conjugate (MCC) Vaccines Given at 3 and 4 Months of Age, and Followed by the Administration at 12 Months of Age of a Combined Haemophilus Influenzae Type b-MCC Vaccine

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01553279

Enrollment

284

Registered

2012-03-14

Start date

2012-03-30

Completion date

2013-09-27

Last updated

2019-03-28

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

Conditions

Neisseria Meningitidis, Bacterial Infections, Virus Diseases

Brief summary

The primary objectives of this study are to evaluate the immunogenicity and safety of concomitant administration of V419 (PR51) with 2 types of meningococcal serogroup C conjugate (MCC) vaccines to healthy infants at 3 and 4 months of age in terms of antibody seroprotection rate (SPR) to MCC. Participants also received a Haemophilus influenza type B (Hib)-MCC vaccination at 12 months of age. It was hypothesized that the SPR to MCC at 1 month post-dose 2 of either tetanus toxoid conjugated Meningo C (MCC-TT) or CRM197 conjugated Meningo C (MCC-CRM) vaccines would be acceptable when administered concomitantly with V419.

Interventions

BIOLOGICALV419

Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, inactivated Poliovirus, Haemophilus b conjugate \[meningococcal outer membrane protein complex\], and Hepatitis B \[recombinant\] vaccine administered via 0.5 mL intramuscular injection.

BIOLOGICALPREVNAR 13®

Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination).

BIOLOGICALMCC-TT

Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age

BIOLOGICALMCC-CRM

Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age

BIOLOGICALHib-MCC

Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.

BIOLOGICALMMR Vaccine

Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

46 Days to 74 Days

Healthy volunteers

Yes

Inclusion criteria

* Healthy infant 46 to 74 days of age (both inclusive) * Parent(s)/legal representative able to comply will the study procedures

Exclusion criteria

* Is participating in a study with an investigational compound or device since birth * Has a history of congenital or acquired immunodeficiency * Has a history of leukemia, lymphoma, malignant melanoma or myeloproliferative disorder * Has a chronic illness that could interfere with study conduct or completion * Has hypersensitivity to any of the vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or contraindication to any of the study vaccines * Has a history, or mother has a history, of hepatitis B virus surface antigen (HBsAg) seropositivity * Has a coagulation disorder that contraindicate intramuscular injection * Has a history of vaccination with a hepatitis B, Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acellular or whole-cell), poliovirus, pneumococcal conjugate or polysaccharide, meningococcal serogroup C conjugate, measles, mumps, or rubella containing vaccine(s) * Has a history of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, invasive pneumococcal, meningococcal serogroup C, measles, mumps or rubella infection * Has received immune globulin, blood or blood-derived products, immunosuppressive agents systemic corticosteroids since birth * Has received vaccination with an inactivated (except influenza vaccine) or conjugated or live vaccine in the last 30 days or vaccination with an inactivated influenza vaccine in the last 14 days * Has received antipyretic, analgesic and non-steroidal anti-inflammatory medications in the last 48 hours * Has a febrile illness or body temperature ≥38.0°C in the last 24 hours

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1)	Month 5 (1 month after MCC-TT/MCC-CRM Dose 2)	The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.

Secondary

Measure	Time frame	Description
Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)	Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)	The percentage of participants with anti-MCC Ab titres ≥1:8 dil and ≥1:128 dil 1 month after MCC-TT or MCC-CRM Doses 1 and 2 was determined in participants also treated with V419. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)	Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)	Anti-MCC antibody GMTs were determined 1 month after MCC-TT or MCC-CRM Doses 1 and 2 in participants also treated with V419. Serum antibody levels were assayed using the Meningo C rabbit complement serum bactericidal antibody (rSBA) assay.
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Month 5 (1 month after V419 Dose 3)	The percentage of participants meeting Ab response rates for V14 antigens was determined after V114 Dose 3. Antibody response rate criteria for Haemophilus influenza Type B (PRP); hepatitis B (HBsAg); diphtheria; tetanus; and polio types 1, 2, and 3 are shown in the rows below. The percentage of seroresponders to pertussis seroresponders (pertussis toxoid \[PT\]; filamentous haemagglutinin (FHA); fimbrae types 2 and 3 \[FIM\]; and pertactin \[PRN\]) was determined as 1) if pre-vaccination Ab concentration \<lower limit of quantification (LLoQ) but post-vaccination Ab concentration ≥LLoQ; or 2) if pre-vaccination Ab concentration was ≥LLoQ but post-vaccination Ab concentration was ≥pre-immunization levels. Antibody titres were measured by RIA for PRP, enhanced chemiluminescence assay (ECi) for HBsAg, micrometabolic inhibition test (MIT) for diphtheria and poliovirus, and enzyme-linked immunosorbent assay (ELISA) for tetanus, PT, FHA, FIM, and PRN.
Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2)	Month 5 (1 month after V419 Dose 3)	The GMTs for PRP Ab titres were determined for each arm. Antibody titres for PRP were measured by radioimmunoassay (RIA).
Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2)	Month 5 (1 month after V419 Dose 3)	The GMTs for HBsAg Ab titres were determined for each arm. Antibody titres for HBsAg were measured by enhanced chemiluminescence (ECi) assay.
Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2)	Month 5 (1 month after V419 Dose 3)	The GMTs for diphtheria Ab titres were determined for each arm. Antibody titres for diptheria were measured by enhanced micrometabolic inhibition test (MIT).
Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2)	Month 5 (1 month after V419 Dose 3)	The GMTs for tetanus Ab titres were determined for each arm. Antibody titres for tetanus were determined with enzyme-linked immunosorbent assay (ELISA).
Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2)	Month 5 (1 month after V419 Dose 3)	The GMTs for PT Ab titres were determined for each arm. Antibody titres for PT were measured with enzyme-linked immunosorbent assay (ELISA).
Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2)	Month 5 (1 month after V419 Dose 3)	The GMTs for FHA were determined for each arm. Antibody titres for FHA were measured by enhanced chemiluminescence (ECi) assay.
Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2)	Month 5 (1 month after V419 Dose 3)	The GMTs for PRN were determined for each arm. Antibody titres for PRN were measured by enhanced chemiluminescence (ECi) assay.
Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2)	Month 5 (1 month after V419 Dose 3)	The GMTs for FIM were determined for each arm. Antibody titres for FIM were measured by enhanced chemiluminescence (ECi) assay.
Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)	Month 5 (1 month after V419 Dose 3)	The GMTs for polio types 1, 2, and 3 were determined for each arm. Antibody titres for polio types 1, 2, and 3 were measured by micrometabolic inhibition test (MIT).
Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)	Month 5 (1 month after V419 Dose 3)	The acceptability (i.e., percentage of participants with anti-PRP Ab titre ≥0.15 µg/mL) of the seroprotection rate (SPR) to Haemophilus influenza type b (Hib) was determined 1 month after the third dose of V419 in participants also treated with MCC-TT or MCC-CRM. The pooled (i.e., all V419-treated participants) SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>80%. Serum Ab levels were determined with radioimmunoassay (RIA).
Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)	Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)	Antibody GMTs were were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)	Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)	The percentage of participants with anti-PRP Ab titres ≥0.15 µg/mL and ≥1.0 µg/mL was determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA).
Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)	Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)	Anti-PRP Ab GMTs were determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA) and are expressed as µg/mL..
Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]	Up to 4.5 months (up to 15 days after the final Part 1 vaccination)	An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product.
Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1]	Up to 4.5 months (up to 15 days after the final Part 1 vaccination)	An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. As per protocol, all injection site AEs were considered vaccine-related.
Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)	Up to 4.5 months (up to 15 days after the final Part 1 vaccination)	The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.
Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)	Up to 4.5 months (up to 15 days after the final Part 1 vaccination)	The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs were any injection-site ISRs not considered solicited.
Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Up to 4.5 months (up to 15 days after the final Part 1 vaccination)	The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.
Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Up to 4.5 months (up to 15 days after the final Part 1 vaccination)	The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs consisted of bruising, dermatitis, erythema, induration, mass, pain, rash, and warmth.
Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]	Up to 4.5 months (up to 15 days after the final Part 1 vaccination)	The percentage of participants with solicited systemic AEs was determined for each arm. Solicited systemic AEs consisted of crying, decreased appetite, irritability, pyrexia, somnolence, and vomiting.
Percentage of Participants Experiencing Increased Temperature [Part 1]	Up to 4.5 months (up to 15 days after the final Part 1 vaccination)	The percentage of participants experiencing temperatures ≥38.0° Celsius (C), \>38.5° C, and \>39.5° C following any Part 1 vaccination was determined.
Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]	Up to 4.5 months (up to 15 days after the final Part 1 vaccination)	An SAE is an event that results in death; is life-threatening; results in or prolongs hospitalization; is a congenital anomaly/birth defect; is a cancer; is an overdose; or is another important medical event that may jeopardize the participant.
Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)	Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)	The percentage of participants with anti-Hib Ab titres ≥1:8 (1/dil) and ≥1:28 (1/dil) were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.

Participant flow

Recruitment details

Infant participants were enrolled at 11 study sites in the United Kingdom.

Participants by arm

Arm	Count
V419 and MCC-TT In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).	142
V419 and MCC-CRM In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).	142
Total	284

Withdrawals & dropouts

Period	Reason	FG000	FG001
Interim Period	Lost to Follow-up	1	0
Interim Period	Withdrawal by Subject	2	2
Part 1 (Infant Vaccinations)	Lost to Follow-up	1	0
Part 1 (Infant Vaccinations)	Withdrawal by Subject	1	1
Period 2: Toddler Vaccinations	Lost to Follow-up	3	2
Period 2: Toddler Vaccinations	Withdrawal by Subject	0	5

Baseline characteristics

Characteristic	V419 and MCC-TT	V419 and MCC-CRM	Total
Age, Continuous	62.6 Days STANDARD_DEVIATION 6.7	61.6 Days STANDARD_DEVIATION 7.2	62.1 Days STANDARD_DEVIATION 7
Sex: Female, Male Female	62 Participants	67 Participants	129 Participants
Sex: Female, Male Male	80 Participants	75 Participants	155 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 142	0 / 142
other Total, other adverse events	140 / 142	137 / 142
serious Total, serious adverse events	6 / 142	4 / 142

Outcome results

Primary

Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1)

The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.

Time frame: Month 5 (1 month after MCC-TT/MCC-CRM Dose 2)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Value (NUMBER)
V419 and MCC-TT	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1)	100.0 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1)	99.1 Percentage of Participants

Secondary

Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2)

The GMTs for diphtheria Ab titres were determined for each arm. Antibody titres for diptheria were measured by enhanced micrometabolic inhibition test (MIT).

Time frame: Month 5 (1 month after V419 Dose 3)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Value (GEOMETRIC_MEAN)
V419 and MCC-TT	Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2)	0.198 IU/mL
V419 and MCC-CRM	Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2)	0.22 IU/mL

Secondary

Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2)

The GMTs for FHA were determined for each arm. Antibody titres for FHA were measured by enhanced chemiluminescence (ECi) assay.

Time frame: Month 5 (1 month after V419 Dose 3)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Value (GEOMETRIC_MEAN)
V419 and MCC-TT	Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2)	50.4 EU/mL
V419 and MCC-CRM	Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2)	50.1 EU/mL

Secondary

Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2)

The GMTs for FIM were determined for each arm. Antibody titres for FIM were measured by enhanced chemiluminescence (ECi) assay.

Time frame: Month 5 (1 month after V419 Dose 3)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Value (GEOMETRIC_MEAN)
V419 and MCC-TT	Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2)	401.7 EU/mL
V419 and MCC-CRM	Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2)	441.7 EU/mL

Secondary

Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2)

The GMTs for PRP Ab titres were determined for each arm. Antibody titres for PRP were measured by radioimmunoassay (RIA).

Time frame: Month 5 (1 month after V419 Dose 3)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Value (GEOMETRIC_MEAN)
V419 and MCC-TT	Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2)	6.44 µg/mL
V419 and MCC-CRM	Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2)	8.21 µg/mL

Secondary

Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2)

The GMTs for HBsAg Ab titres were determined for each arm. Antibody titres for HBsAg were measured by enhanced chemiluminescence (ECi) assay.

Time frame: Month 5 (1 month after V419 Dose 3)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Value (GEOMETRIC_MEAN)
V419 and MCC-TT	Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2)	195.1 mIU/mL
V419 and MCC-CRM	Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2)	247.7 mIU/mL

Secondary

Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2)

The GMTs for PRN were determined for each arm. Antibody titres for PRN were measured by enhanced chemiluminescence (ECi) assay.

Time frame: Month 5 (1 month after V419 Dose 3)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Value (GEOMETRIC_MEAN)
V419 and MCC-TT	Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2)	90.4 EU/mL
V419 and MCC-CRM	Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2)	106.8 EU/mL

Secondary

Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2)

The GMTs for PT Ab titres were determined for each arm. Antibody titres for PT were measured with enzyme-linked immunosorbent assay (ELISA).

Time frame: Month 5 (1 month after V419 Dose 3)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Value (GEOMETRIC_MEAN)
V419 and MCC-TT	Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2)	131.5 EU/mL
V419 and MCC-CRM	Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2)	133.3 EU/mL

Secondary

Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)

The GMTs for polio types 1, 2, and 3 were determined for each arm. Antibody titres for polio types 1, 2, and 3 were measured by micrometabolic inhibition test (MIT).

Time frame: Month 5 (1 month after V419 Dose 3)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
V419 and MCC-TT	Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)	Anti-Polio 1 GMT	214 titre (1/dil)
V419 and MCC-TT	Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)	Anti-Polio 2 GMT	385.2 titre (1/dil)
V419 and MCC-TT	Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)	Anti-Polio 3 GMT	502.2 titre (1/dil)
V419 and MCC-CRM	Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)	Anti-Polio 1 GMT	257.9 titre (1/dil)
V419 and MCC-CRM	Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)	Anti-Polio 2 GMT	400.6 titre (1/dil)
V419 and MCC-CRM	Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)	Anti-Polio 3 GMT	405.1 titre (1/dil)

Secondary

Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2)

The GMTs for tetanus Ab titres were determined for each arm. Antibody titres for tetanus were determined with enzyme-linked immunosorbent assay (ELISA).

Time frame: Month 5 (1 month after V419 Dose 3)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Value (GEOMETRIC_MEAN)
V419 and MCC-TT	Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2)	1.03 IU/mL
V419 and MCC-CRM	Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2)	0.95 IU/mL

Secondary

Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)

Antibody GMTs were were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.

Time frame: Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)

Population: All randomized and treated participants with data available, who had no protocol violations that could interfere with results, and received all Part 1 vaccinations are included.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
V419 and MCC-TT	Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)	Pre-Hib anti-MCC GMT	50.3 tire (1/dil)
V419 and MCC-TT	Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)	Post-Hib anti-MCC GMT	3257.9 tire (1/dil)
V419 and MCC-CRM	Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)	Pre-Hib anti-MCC GMT	8.7 tire (1/dil)
V419 and MCC-CRM	Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)	Post-Hib anti-MCC GMT	580.8 tire (1/dil)

Secondary

Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)

The percentage of participants meeting Ab response rates for V14 antigens was determined after V114 Dose 3. Antibody response rate criteria for Haemophilus influenza Type B (PRP); hepatitis B (HBsAg); diphtheria; tetanus; and polio types 1, 2, and 3 are shown in the rows below. The percentage of seroresponders to pertussis seroresponders (pertussis toxoid \[PT\]; filamentous haemagglutinin (FHA); fimbrae types 2 and 3 \[FIM\]; and pertactin \[PRN\]) was determined as 1) if pre-vaccination Ab concentration \<lower limit of quantification (LLoQ) but post-vaccination Ab concentration ≥LLoQ; or 2) if pre-vaccination Ab concentration was ≥LLoQ but post-vaccination Ab concentration was ≥pre-immunization levels. Antibody titres were measured by RIA for PRP, enhanced chemiluminescence assay (ECi) for HBsAg, micrometabolic inhibition test (MIT) for diphtheria and poliovirus, and enzyme-linked immunosorbent assay (ELISA) for tetanus, PT, FHA, FIM, and PRN.

Time frame: Month 5 (1 month after V419 Dose 3)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Group	Value (NUMBER)
V419 and MCC-TT	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-Diptheria ≥0.01 IU/mL	100.0 Percentage of Participants
V419 and MCC-TT	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-FHA seroresponse	91.0 Percentage of Participants
V419 and MCC-TT	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-Tetanus ≥0.01 IU/mL	100.0 Percentage of Participants
V419 and MCC-TT	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-PRN seroresponse	95.0 Percentage of Participants
V419 and MCC-TT	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-HBsAG ≥10 mIU/mL	96.8 Percentage of Participants
V419 and MCC-TT	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-FIM seroresponse	96.0 Percentage of Participants
V419 and MCC-TT	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-Tetanus ≥0.1 IU/mL	100.0 Percentage of Participants
V419 and MCC-TT	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-Polio 1 ≥ 1:8 dil	100.0 Percentage of Participants
V419 and MCC-TT	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-Diptheria ≥0.1 IU/mL	68.0 Percentage of Participants
V419 and MCC-TT	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-Polio 2 ≥ 1:8 dil	100.0 Percentage of Participants
V419 and MCC-TT	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-PT seroresponse	99.0 Percentage of Participants
V419 and MCC-TT	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-Polio 3 ≥ 1:8 dil	100.0 Percentage of Participants
V419 and MCC-TT	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-PRP ≥0.15 µg/mL	97.8 Percentage of Participants
V419 and MCC-CRM	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-Polio 3 ≥ 1:8 dil	100.0 Percentage of Participants
V419 and MCC-CRM	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-PRP ≥0.15 µg/mL	100.0 Percentage of Participants
V419 and MCC-CRM	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-HBsAG ≥10 mIU/mL	96.3 Percentage of Participants
V419 and MCC-CRM	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-Diptheria ≥0.01 IU/mL	100.0 Percentage of Participants
V419 and MCC-CRM	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-Diptheria ≥0.1 IU/mL	74.0 Percentage of Participants
V419 and MCC-CRM	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-Tetanus ≥0.01 IU/mL	100.0 Percentage of Participants
V419 and MCC-CRM	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-Tetanus ≥0.1 IU/mL	100.0 Percentage of Participants
V419 and MCC-CRM	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-PT seroresponse	100.0 Percentage of Participants
V419 and MCC-CRM	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-FHA seroresponse	90.5 Percentage of Participants
V419 and MCC-CRM	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-PRN seroresponse	90.4 Percentage of Participants
V419 and MCC-CRM	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-FIM seroresponse	96.0 Percentage of Participants
V419 and MCC-CRM	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-Polio 1 ≥ 1:8 dil	100.0 Percentage of Participants
V419 and MCC-CRM	Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)	Anti-Polio 2 ≥ 1:8 dil	100.0 Percentage of Participants

Secondary

Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)

Anti-PRP Ab GMTs were determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA) and are expressed as µg/mL..

Time frame: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
V419 and MCC-TT	Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)	Pre-Hib-MCC anti-PRP ≥0.15 µg/mL	1.09 µg/mL
V419 and MCC-TT	Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)	Pre-Hib-MCC anti-PRP ≥1.0 µg/mL	100.19 µg/mL
V419 and MCC-CRM	Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)	Pre-Hib-MCC anti-PRP ≥0.15 µg/mL	1.18 µg/mL
V419 and MCC-CRM	Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)	Pre-Hib-MCC anti-PRP ≥1.0 µg/mL	121.00 µg/mL

Secondary

Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)

Anti-MCC antibody GMTs were determined 1 month after MCC-TT or MCC-CRM Doses 1 and 2 in participants also treated with V419. Serum antibody levels were assayed using the Meningo C rabbit complement serum bactericidal antibody (rSBA) assay.

Time frame: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
V419 and MCC-TT	Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)	Post-MCC Dose 1 anti-MCC GMTs	1353 Titres
V419 and MCC-TT	Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)	Post-MCC Dose 2 anti-MCC GMTs	2024.7 Titres
V419 and MCC-CRM	Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)	Post-MCC Dose 1 anti-MCC GMTs	285.0 Titres
V419 and MCC-CRM	Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)	Post-MCC Dose 2 anti-MCC GMTs	1077.4 Titres

Secondary

Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product.

Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.

Arm	Measure	Value (NUMBER)
V419 and MCC-TT	Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]	98.6 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]	97.2 Percentage of Participants

Secondary

Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1]

Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.

Arm	Measure	Value (NUMBER)
V419 and MCC-TT	Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1]	98.6 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1]	96.5 Percentage of Participants

Secondary

Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)

The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs consisted of bruising, dermatitis, erythema, induration, mass, pain, rash, and warmth.

Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.

Arm	Measure	Group	Value (NUMBER)
V419 and MCC-TT	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Bruising	1.4 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Dermatitis	0 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Erythema	0 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Induration	1.4 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Mass	3.5 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Pain	0 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Rash	1.4 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Warmth	0 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Warmth	2.1 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Bruising	4.2 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Mass	2.1 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Dermatitis	0.7 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Rash	0.7 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Erythema	0.7 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Pain	0.7 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Induration	0.7 Percentage of Participants

Secondary

Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)

The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs were any injection-site ISRs not considered solicited.

Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.

Arm	Measure	Value (NUMBER)
V419 and MCC-TT	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)	6.3 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)	11.3 Percentage of Participants

Secondary

Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]

An SAE is an event that results in death; is life-threatening; results in or prolongs hospitalization; is a congenital anomaly/birth defect; is a cancer; is an overdose; or is another important medical event that may jeopardize the participant.

Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.

Arm	Measure	Value (NUMBER)
V419 and MCC-TT	Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]	4.2 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]	2.8 Percentage of Participants

Secondary

Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)

The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.

Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.

Arm	Measure	Group	Value (NUMBER)
V419 and MCC-TT	Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Erythema	56.3 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Pain	41.5 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Swelling	35.9 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Erythema	45.8 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Pain	45.8 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)	Swelling	28.2 Percentage of Participants

Secondary

Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)

The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.

Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.

Arm	Measure	Group	Value (NUMBER)
V419 and MCC-TT	Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)	Erythema	71.1 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)	Pain	63.4 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)	Swelling	51.4 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)	Erythema	64.8 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)	Pain	66.2 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)	Swelling	47.2 Percentage of Participants

Secondary

Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]

The percentage of participants with solicited systemic AEs was determined for each arm. Solicited systemic AEs consisted of crying, decreased appetite, irritability, pyrexia, somnolence, and vomiting.

Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.

Arm	Measure	Group	Value (NUMBER)
V419 and MCC-TT	Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]	Crying	85.9 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]	Decreased appetite	63.4 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]	Irritability	88.0 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]	Pyrexia	11.3 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]	Somnolence	81.7 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]	Vomiting	40.1 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]	Somnolence	78.9 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]	Crying	81.0 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]	Pyrexia	10.6 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]	Decreased appetite	64.8 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]	Vomiting	49.3 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]	Irritability	81.0 Percentage of Participants

Secondary

Percentage of Participants Experiencing Increased Temperature [Part 1]

The percentage of participants experiencing temperatures ≥38.0° Celsius (C), \>38.5° C, and \>39.5° C following any Part 1 vaccination was determined.

Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.

Arm	Measure	Group	Value (NUMBER)
V419 and MCC-TT	Percentage of Participants Experiencing Increased Temperature [Part 1]	% ≥38.0° C	11.3 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing Increased Temperature [Part 1]	% >38.5° C	1.4 Percentage of Participants
V419 and MCC-TT	Percentage of Participants Experiencing Increased Temperature [Part 1]	% >39.5° C	0.0 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing Increased Temperature [Part 1]	% ≥38.0° C	10.6 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing Increased Temperature [Part 1]	% >38.5° C	2.1 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants Experiencing Increased Temperature [Part 1]	% >39.5° C	0.0 Percentage of Participants

Secondary

Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)

The percentage of participants with anti-Hib Ab titres ≥1:8 (1/dil) and ≥1:28 (1/dil) were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.

Time frame: Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)

Population: All randomized and treated participants with data available, who had no protocol violations that could interfere with results, and received all Part 1 vaccinations are included.

Arm	Measure	Group	Value (NUMBER)
V419 and MCC-TT	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)	Pre-Hib anti-MCC: % with titre ≥1:8 (1/dil)	83.1 Percentage of Participants
V419 and MCC-TT	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)	Pre-Hib anti-MCC: % with titre ≥1:28 (1/dil)	40.4 Percentage of Participants
V419 and MCC-TT	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)	Post-Hib anti-MCC: % with titre ≥1:8 (1/dil)	100.0 Percentage of Participants
V419 and MCC-TT	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)	Post-Hib anti-MCC: % with titre ≥1:28 (1/dil)	99.1 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)	Post-Hib anti-MCC: % with titre ≥1:28 (1/dil)	95.5 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)	Pre-Hib anti-MCC: % with titre ≥1:8 (1/dil)	40.4 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)	Post-Hib anti-MCC: % with titre ≥1:8 (1/dil)	97.3 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)	Pre-Hib anti-MCC: % with titre ≥1:28 (1/dil)	16.0 Percentage of Participants

Secondary

Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)

The percentage of participants with anti-MCC Ab titres ≥1:8 dil and ≥1:128 dil 1 month after MCC-TT or MCC-CRM Doses 1 and 2 was determined in participants also treated with V419. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.

Time frame: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Group	Value (NUMBER)
V419 and MCC-TT	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)	Post-MCC Dose 1: % with ≥1:8 dil	100.0 Percentage of Participants
V419 and MCC-TT	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)	Post-MCC Dose 1: % with ≥1:128 dil	98.0 Percentage of Participants
V419 and MCC-TT	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)	Post-MCC Dose 2: % with ≥1:8 dil	100.0 Percentage of Participants
V419 and MCC-TT	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)	Post-MCC Dose 2: % with ≥1:128 dil	99.2 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)	Post-MCC Dose 2: % with ≥1:128 dil	99.1 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)	Post-MCC Dose 1: % with ≥1:8 dil	96.4 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)	Post-MCC Dose 2: % with ≥1:8 dil	99.1 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)	Post-MCC Dose 1: % with ≥1:128 dil	84.5 Percentage of Participants

Secondary

Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)

The acceptability (i.e., percentage of participants with anti-PRP Ab titre ≥0.15 µg/mL) of the seroprotection rate (SPR) to Haemophilus influenza type b (Hib) was determined 1 month after the third dose of V419 in participants also treated with MCC-TT or MCC-CRM. The pooled (i.e., all V419-treated participants) SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>80%. Serum Ab levels were determined with radioimmunoassay (RIA).

Time frame: Month 5 (1 month after V419 Dose 3)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Value (NUMBER)
V419 and MCC-TT	Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)	98.9 Percentage of Participants

Secondary

Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)

The percentage of participants with anti-PRP Ab titres ≥0.15 µg/mL and ≥1.0 µg/mL was determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA).

Time frame: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)

Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.

Arm	Measure	Group	Value (NUMBER)
V419 and MCC-TT	Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)	Pre-Hib-MCC anti-PRP ≥0.15 µg/mL	93.9 Percentage of Participants
V419 and MCC-TT	Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)	Pre-Hib-MCC anti-PRP ≥1.0 µg/mL	54.9 Percentage of Participants
V419 and MCC-TT	Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)	Post-Hib-MCC anti-PRP ≥0.15 µg/mL	100.0 Percentage of Participants
V419 and MCC-TT	Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)	Post-Hib-MCC anti-PRP ≥1.0 µg/mL	99.1 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)	Post-Hib-MCC anti-PRP ≥1.0 µg/mL	100.0 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)	Pre-Hib-MCC anti-PRP ≥0.15 µg/mL	95.4 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)	Post-Hib-MCC anti-PRP ≥0.15 µg/mL	100.0 Percentage of Participants
V419 and MCC-CRM	Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)	Pre-Hib-MCC anti-PRP ≥1.0 µg/mL	56.3 Percentage of Participants

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

Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1)

Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2)

Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2)

Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2)

Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2)

Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2)

Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2)

Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2)

Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)

Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2)

Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)

Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)

Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)

Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)

Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]

Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1]

Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)

Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)

Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]

Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)

Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)

Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]

Percentage of Participants Experiencing Increased Temperature [Part 1]

Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)

Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)

Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)

Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)