Neisseria Meningitidis, Bacterial Infections, Virus Diseases
Conditions
Brief summary
To evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age Primary objectives * To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (HB) one month after completion of the mixed schedule * To demonstrate that the mixed schedule induces acceptable responses for Haemophilus influenzae type b (Hib) one month after completion of the mixed schedule Secondary objectives * To describe the antibody response to all PR5I antigens one month after completion of the mixed schedule * To describe the antibody response to meningococcal serogroup C (MCC) conjugate vaccine one month after the second dose of MenC vaccine * To describe the safety profile after each dose of study vaccines administered
Interventions
BIOLOGICALPR5I
Hexavalent PR5I vaccine (DTaP-HB-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed \[DTaP\], Hepatitis B \[HB; Recombinant DNA\], Inactivated Poliovirus \[IPV\], and Haemophilus influenzae type b \[Hib\] conjugate vaccine \[adsorbed\]) at 0.5 mL for IM injection (left upper thigh) at 2 and 6 months of age.
BIOLOGICALPediacel®
Pentavalent Pediacel® vaccine (DTaP-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed \[DTaP\], Inactivated Poliovirus \[IPV\], and Haemophilus influenzae type b \[Hib\] conjugate vaccine \[adsorbed\]) at 0.5 mL for IM injection (left upper thigh) at 4 months of age.
BIOLOGICALNeisVac-C®
Meningococcal group C (MCC) polysaccharide conjugate vaccine (adsorbed) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.
BIOLOGICALRotaTeq®
Human-bovine rotavirus reassortants (live) vaccine 2 mL oral administration at 2, 4 and 6 months of age. RotaTeq® administered prior to any other vaccine administration to avoid having the infant participants spit up the RotaTeq® when crying.
BIOLOGICALPrevenar 13®
Pneumococcal polysaccharide conjugate vaccine \[PCV; 13-valent, adsorbed\]) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.
Sponsors
Sanofi Pasteur, a Sanofi Company
Merck Sharp & Dohme LLC
MCM Vaccines B.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
46 Days to 76 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy infant 46 to 74 days (both inclusive) * Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth * Parent(s)/legal representative able to comply with the study procedures
Exclusion criteria
* Participation in any study with an investigational compound or device since birth * History of congenital or acquired immunodeficiency * Chronic illness that could interfere with study conduct or completion * Hypersensitivity to any of the study vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines * Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq® * History or maternal history of HBsAg seropositivity * Coagulation disorder that contraindicate intramuscular injection * History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s) * History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection * Receipt of immune globulin, blood or blood-derived products since birth * Receipt of systemic corticosteroids for more than 14 consecutive days within one month of the study start * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL | Month 5 (one month after receiving Vaccination 3) | The percentage of participants with an anti-HBsAg antibody titer ≥10 mill-International Units/mL (mIU/mL) was assessed. Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the concentration of antibodies to HBsAg. |
| Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL | Month 5 (one month after receiving Vaccination 3) | The percentage of participants with an anti-Polyribosylribitol Phosphate (PRP) antibody titer ≥0.15 µg/mL was assessed. Participant serum samples were collected for analysis by radioimmunoassay to determine the concentration of antibodies to PRP, a Haemophilus influenzae type b (Hib) capsular polysaccharide. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg) | Month 5 (one month after receiving Vaccination 3) | Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the geometric mean concentration of antibodies to Hepatitis B Surface Antigen (HBsAg). The unit of measure is milli International Units/mL (mIU/mL). |
| Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen | Month 5 (one month after receiving Vaccination 3) | Participant serum samples were collected for analysis by radioimmunoassay (RIA) to determine the geometric mean concentration of antibodies to polyribosylribitol phosphate (PRP), a Haemophilus influenzae type b (Hib) capsular polysaccharide. |
| Geometric Mean Concentration of Antibodies to Diphtheria Toxin | Month 5 (one month after receiving Vaccination 3) | Participant serum samples were collected for analysis with a Micrometabolic Inhibition Test (MIT) to determine the geometric mean concentration of neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL). |
| Geometric Mean Concentration of Antibodies to Tetanus Toxin | Month 5 (one month after receiving Vaccination 3) | Participant serum samples were collected for analysis by Enzyme-linked Immunosorbent Assay (ELISA) to determine the geometric mean concentration of antibodies to tetanus toxin. The unit of measure is International Units/mL (IU/mL). |
| Geometric Mean Concentrations of Antibodies to Pertussis Antigens | Month 5 (one month after receiving Vaccination 3) | Participant serum samples were collected for analysis by ELISA to determine the geometric mean concentration of antibodies (Abs) to the following Pertussis antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN) and fimbriae types (FIM) 2&3. The unit of measure is ELISA Units/mL (EU/mL). |
| Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3) | Month 5 (one month after receiving Vaccination 3) | Participant serum samples were collected for analysis with a Micrometabolic Inhibition Test (MIT) to determine the geometric mean titer of neutralizing antibodies (Abs) to Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3). The unit of measure is titer, expressed as the reciprocal dilution of the highest dilution that neutralizes 50% of the challenge virus. |
| Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3) | Month 5 (one month after receiving Vaccination 3) | Participants were considered as responding if the observed concentration or titer for antibodies (Abs) to specific antigens exceeded the following thresholds: 1. For anti-PRP Abs (Hib capsular polysaccharide) - Response defined as a concentration ≥1 µg/mL (measured by RIA); 2. For anti-D Abs - Response defined at 2 concentrations: ≥0.01 IU/mL and ≥0.10 IU/mL (measured by MIT); 3. For anti-T Abs - Response defined at 2 concentrations: ≥0.01 IU/mL and ≥0.10 IU/mL (measured by ELISA); 4. For anti-IPV1, anti-IPV2, and anti-IPV3 Abs - Response defined as a titer ≥ 8 (measured by MIT). The percentage of participants considered as responding to the individual antigen (per the response threshold\[s\]) were assessed. |
| Geometric Mean Titer of Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibodies | Month 3 (one month after receiving Vaccination 2) | Participant serum samples were collected to determine the geometric mean titer of anti-MCC antibodies, measured by the Serum Bactericidal Antibody assay using rabbit complement (rSBA). The unit of measure is titer, expressed as the reciprocal of the final serum dilution giving ≥50% killing of the challenge bacterial strain. |
| Percentage of Participants With an Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibody Titer ≥8 | Month 3 (one month after receiving Vaccination 2) | The percentage of participants with an anti-MCC antibody titer ≥8 was assessed. Participant serum samples were collected and analyzed for anti-MCC antibodies with the Serum Bactericidal Antibody assay using rabbit complement (rSBA). |
| Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination | Up to Day 5 following each vaccination | The percentage of participants with a body temperature ≥38.0°C from Day 1 to Day 5 after each vaccination was assessed. Per protocol, the participant's parent(s)/legal representative recorded daily body temperature measurements each evening by the axillary route (N=3 collected via rectal route; N=1 collected via oral route) and recorded these observations on the Vaccine Report Card (VRC). Temperatures were based on actual temperatures recorded with no adjustments for the route of assessment. |
| Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Up to Day 5 following each vaccination | The number of participants experiencing solicited ISRs related to the PRI5 or Pediacel® vaccination was assessed. Solicited ISRs (erythema, pain and swelling) occurring at the PR5I or Pediacel® injection site were always considered related to the PR5I or Pediacel® vaccine, respectively. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing solicited ISRs up to Day 5 after each vaccination and after any vaccination. |
| Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Up to Day 5 following each vaccination | The number of participants experiencing solicited ISRs related to the NeisVac-C® (MCC) vaccination was assessed. Solicited ISRs (erythema, pain and swelling) occurring at the NeisVac-C® (MCC) injection site were always considered related to the NeisVac-C® (MCC) vaccine. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing solicited ISRs up to Day 5 after each NeisVac-C® vaccination and after any NeisVac-C® vaccination. |
| Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Up to Day 15 following each vaccination | The number of participants experiencing unsolicited ISRs related to the PRI5 or Pediacel® vaccination was assessed. Unsolicited ISRs occurring at the PR5I or Pediacel® injection site were always considered related to the PR5I or Pediacel® vaccine, respectively. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing unsolicited ISRs up to Day 15 after each vaccination and after any vaccination. |
| Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Up to Day 15 following each vaccination | The number of participants experiencing unsolicited ISRs related to the NeisVac-C® (MCC) vaccination was assessed. Unsolicited ISRs occurring at the NeisVac-C® (MCC) injection site were always considered related to the NeisVac-C® (MCC) vaccine. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing unsolicited ISRs up to Day 15 after each NeisVac-C® vaccination and after any NeisVac-C® vaccination. |
| Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Up to Day 5 following each vaccination | The number of participants experiencing solicited systemic AEs (crying, decreased appetite, irritability, somnolence, pyrexia, and vomiting) was assessed. Each day from Day 1 to Day 5 following each vaccination, the participant's parent(s)/legal representative recorded all solicited AEs on the VRC. Data are presented for the number of participants experiencing solicited AEs up to Day 5 after each vaccination and after any vaccination. |
| Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE) | Up to Day 15 following each vaccination | The number of participants experiencing unsolicited systemic AEs was assessed. Data are presented for the number of participants experiencing unsolicited AEs up to Day 15 after each vaccination and after any vaccination. |
| Number of Participants Experiencing a Serious Adverse Event (SAE) | Up to ~6 months (at any time during the study) | An SAE is an adverse event (AE) that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially require medical or surgical intervention. |
Participant flow
Recruitment details
The study enrolled N=385 infant participants previously vaccinated with only 1 dose of monovalent Hepatitis B vaccine, within 3 days after birth, outside of study context.
Pre-assignment details
Participants progressed through the study as a single group, with all participants receiving the same mixed-schedule vaccination series. Vaccination (V1) was administered on Study Day 0 (2 months of age), with V2 (4 months of age) and V3 (6 months of age) administered at Study Months 2 and 4, respectively.
Participants by arm
| Arm | Count |
|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) \[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age. | 385 |
| Total | 385 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | PR5I (V1); Pediacel® (V2); PR5I (V3) |
|---|---|
| Age, Continuous | 60.72 Days STANDARD_DEVIATION 7.75 |
| Body Weight | 5.14 kg STANDARD_DEVIATION 0.59 |
| Sex: Female, Male Female | 199 Participants |
| Sex: Female, Male Male | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 385 |
| other Total, other adverse events | 360 / 385 |
| serious Total, serious adverse events | 12 / 385 |
Outcome results
Primary
Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL
The percentage of participants with an anti-HBsAg antibody titer ≥10 mill-International Units/mL (mIU/mL) was assessed. Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the concentration of antibodies to HBsAg.
Time frame: Month 5 (one month after receiving Vaccination 3)
Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL | 98.9 Percentage of Participants |
Primary
Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL
The percentage of participants with an anti-Polyribosylribitol Phosphate (PRP) antibody titer ≥0.15 µg/mL was assessed. Participant serum samples were collected for analysis by radioimmunoassay to determine the concentration of antibodies to PRP, a Haemophilus influenzae type b (Hib) capsular polysaccharide.
Time frame: Month 5 (one month after receiving Vaccination 3)
Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL | 100.0 Percentage of Participants |
Secondary
Geometric Mean Concentration of Antibodies to Diphtheria Toxin
Participant serum samples were collected for analysis with a Micrometabolic Inhibition Test (MIT) to determine the geometric mean concentration of neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL).
Time frame: Month 5 (one month after receiving Vaccination 3)
Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Geometric Mean Concentration of Antibodies to Diphtheria Toxin | 0.47 IU/mL |
Secondary
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg)
Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the geometric mean concentration of antibodies to Hepatitis B Surface Antigen (HBsAg). The unit of measure is milli International Units/mL (mIU/mL).
Time frame: Month 5 (one month after receiving Vaccination 3)
Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg) | 1054.97 mIU/mL |
Secondary
Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen
Participant serum samples were collected for analysis by radioimmunoassay (RIA) to determine the geometric mean concentration of antibodies to polyribosylribitol phosphate (PRP), a Haemophilus influenzae type b (Hib) capsular polysaccharide.
Time frame: Month 5 (one month after receiving Vaccination 3)
Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen | 8.00 μg/mL |
Secondary
Geometric Mean Concentration of Antibodies to Tetanus Toxin
Participant serum samples were collected for analysis by Enzyme-linked Immunosorbent Assay (ELISA) to determine the geometric mean concentration of antibodies to tetanus toxin. The unit of measure is International Units/mL (IU/mL).
Time frame: Month 5 (one month after receiving Vaccination 3)
Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Geometric Mean Concentration of Antibodies to Tetanus Toxin | 2.44 IU/mL |
Secondary
Geometric Mean Concentrations of Antibodies to Pertussis Antigens
Participant serum samples were collected for analysis by ELISA to determine the geometric mean concentration of antibodies (Abs) to the following Pertussis antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN) and fimbriae types (FIM) 2&3. The unit of measure is ELISA Units/mL (EU/mL).
Time frame: Month 5 (one month after receiving Vaccination 3)
Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Geometric Mean Concentrations of Antibodies to Pertussis Antigens | Anti-PT Abs | 107.46 EU/mL |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Geometric Mean Concentrations of Antibodies to Pertussis Antigens | Anti-FHA Abs | 67.09 EU/mL |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Geometric Mean Concentrations of Antibodies to Pertussis Antigens | Anti-PRN Abs | 56.46 EU/mL |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Geometric Mean Concentrations of Antibodies to Pertussis Antigens | Anti-FIM 2&3 Abs | 360.99 EU/mL |
Secondary
Geometric Mean Titer of Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibodies
Participant serum samples were collected to determine the geometric mean titer of anti-MCC antibodies, measured by the Serum Bactericidal Antibody assay using rabbit complement (rSBA). The unit of measure is titer, expressed as the reciprocal of the final serum dilution giving ≥50% killing of the challenge bacterial strain.
Time frame: Month 3 (one month after receiving Vaccination 2)
Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Geometric Mean Titer of Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibodies | 739.63 Titer |
Secondary
Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3)
Participant serum samples were collected for analysis with a Micrometabolic Inhibition Test (MIT) to determine the geometric mean titer of neutralizing antibodies (Abs) to Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3). The unit of measure is titer, expressed as the reciprocal dilution of the highest dilution that neutralizes 50% of the challenge virus.
Time frame: Month 5 (one month after receiving Vaccination 3)
Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3) | Anti-IPV1 Abs | 663.97 Titer |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3) | Anti-IPV2 Abs | 1198.93 Titer |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3) | Anti-IPV3 Abs | 764.64 Titer |
Secondary
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination
The number of participants experiencing unsolicited ISRs related to the NeisVac-C® (MCC) vaccination was assessed. Unsolicited ISRs occurring at the NeisVac-C® (MCC) injection site were always considered related to the NeisVac-C® (MCC) vaccine. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing unsolicited ISRs up to Day 15 after each NeisVac-C® vaccination and after any NeisVac-C® vaccination.
Time frame: Up to Day 15 following each vaccination
Population: All participants receiving ≥1 dose of NeisVac-C® vaccination with corresponding safety follow-up data after each vaccination (for V1 and V2 arms) and after any vaccination (for V1; V2 arm) with NeisVac-C®.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site haematoma | 0 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site discolouration | 1 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site induration | 2 Participants |
| Pediacel® (V2) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site haematoma | 2 Participants |
| Pediacel® (V2) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site discolouration | 0 Participants |
| Pediacel® (V2) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site induration | 2 Participants |
| PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site discolouration | 1 Participants |
| PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site induration | 4 Participants |
| PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site haematoma | 2 Participants |
Secondary
Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
The number of participants experiencing unsolicited ISRs related to the PRI5 or Pediacel® vaccination was assessed. Unsolicited ISRs occurring at the PR5I or Pediacel® injection site were always considered related to the PR5I or Pediacel® vaccine, respectively. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing unsolicited ISRs up to Day 15 after each vaccination and after any vaccination.
Time frame: Up to Day 15 following each vaccination
Population: All participants receiving ≥1 dose of PR5I/Pediacel® vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm) with PR5I/Pediacel®.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site bruising | 1 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site induration | 5 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site haemorrhage | 0 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site discomfort | 0 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site warmth | 1 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site haematoma | 1 Participants |
| Pediacel® (V2) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site haemorrhage | 1 Participants |
| Pediacel® (V2) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site warmth | 0 Participants |
| Pediacel® (V2) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site haematoma | 1 Participants |
| Pediacel® (V2) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site bruising | 0 Participants |
| Pediacel® (V2) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site induration | 4 Participants |
| Pediacel® (V2) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site discomfort | 1 Participants |
| PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site induration | 8 Participants |
| PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site discomfort | 0 Participants |
| PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site haematoma | 1 Participants |
| PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site bruising | 0 Participants |
| PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site warmth | 1 Participants |
| PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site haemorrhage | 0 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site warmth | 1 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site induration | 16 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site bruising | 1 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site discomfort | 1 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site haematoma | 3 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site haemorrhage | 1 Participants |
Secondary
Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE)
The number of participants experiencing unsolicited systemic AEs was assessed. Data are presented for the number of participants experiencing unsolicited AEs up to Day 15 after each vaccination and after any vaccination.
Time frame: Up to Day 15 following each vaccination
Population: All participants receiving ≥1 dose of any vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE) | 58 Participants |
| Pediacel® (V2) | Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE) | 53 Participants |
| PR5I (V3) | Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE) | 89 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE) | 163 Participants |
Secondary
Number of Participants Experiencing a Serious Adverse Event (SAE)
An SAE is an adverse event (AE) that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially require medical or surgical intervention.
Time frame: Up to ~6 months (at any time during the study)
Population: All participants receiving ≥1 dose of study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Serious Adverse Event (SAE) | 12 Participants |
Secondary
Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination
The number of participants experiencing solicited ISRs related to the NeisVac-C® (MCC) vaccination was assessed. Solicited ISRs (erythema, pain and swelling) occurring at the NeisVac-C® (MCC) injection site were always considered related to the NeisVac-C® (MCC) vaccine. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing solicited ISRs up to Day 5 after each NeisVac-C® vaccination and after any NeisVac-C® vaccination.
Time frame: Up to Day 5 following each vaccination
Population: All participants receiving ≥1 dose of NeisVac-C® vaccination with corresponding safety follow-up data after each vaccination (for V1 and V2 arms) and after any vaccination (for V1; V2 arm) with NeisVac-C®.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site pain | 113 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site erythema | 41 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site swelling | 34 Participants |
| Pediacel® (V2) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site pain | 89 Participants |
| Pediacel® (V2) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site erythema | 59 Participants |
| Pediacel® (V2) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site swelling | 42 Participants |
| PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site erythema | 85 Participants |
| PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site swelling | 66 Participants |
| PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination | Injection-site pain | 151 Participants |
Secondary
Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination
The number of participants experiencing solicited ISRs related to the PRI5 or Pediacel® vaccination was assessed. Solicited ISRs (erythema, pain and swelling) occurring at the PR5I or Pediacel® injection site were always considered related to the PR5I or Pediacel® vaccine, respectively. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing solicited ISRs up to Day 5 after each vaccination and after any vaccination.
Time frame: Up to Day 5 following each vaccination
Population: All participants receiving ≥1 dose of PR5I/Pediacel® vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm) with PR5I/Pediacel®.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site erythema | 81 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site swelling | 68 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site pain | 152 Participants |
| Pediacel® (V2) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site erythema | 65 Participants |
| Pediacel® (V2) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site swelling | 52 Participants |
| Pediacel® (V2) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site pain | 97 Participants |
| PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site pain | 93 Participants |
| PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site erythema | 69 Participants |
| PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site swelling | 65 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site erythema | 136 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site swelling | 121 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination | Injection-site pain | 200 Participants |
Secondary
Number of Participants Experiencing a Solicited Systemic Adverse Event (AE)
The number of participants experiencing solicited systemic AEs (crying, decreased appetite, irritability, somnolence, pyrexia, and vomiting) was assessed. Each day from Day 1 to Day 5 following each vaccination, the participant's parent(s)/legal representative recorded all solicited AEs on the VRC. Data are presented for the number of participants experiencing solicited AEs up to Day 5 after each vaccination and after any vaccination.
Time frame: Up to Day 5 following each vaccination
Population: All participants receiving ≥1 dose of any vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Irritability | 196 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Crying | 188 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Pyrexia | 19 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Somnolence | 184 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Vomiting | 56 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Decreased appetite | 141 Participants |
| Pediacel® (V2) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Vomiting | 35 Participants |
| Pediacel® (V2) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Crying | 131 Participants |
| Pediacel® (V2) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Irritability | 154 Participants |
| Pediacel® (V2) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Decreased appetite | 88 Participants |
| Pediacel® (V2) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Pyrexia | 24 Participants |
| Pediacel® (V2) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Somnolence | 126 Participants |
| PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Pyrexia | 18 Participants |
| PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Vomiting | 27 Participants |
| PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Crying | 102 Participants |
| PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Somnolence | 84 Participants |
| PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Decreased appetite | 76 Participants |
| PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Irritability | 119 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Vomiting | 88 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Crying | 255 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Decreased appetite | 195 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Irritability | 268 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Somnolence | 229 Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) | Pyrexia | 52 Participants |
Secondary
Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3)
Participants were considered as responding if the observed concentration or titer for antibodies (Abs) to specific antigens exceeded the following thresholds: 1. For anti-PRP Abs (Hib capsular polysaccharide) - Response defined as a concentration ≥1 µg/mL (measured by RIA); 2. For anti-D Abs - Response defined at 2 concentrations: ≥0.01 IU/mL and ≥0.10 IU/mL (measured by MIT); 3. For anti-T Abs - Response defined at 2 concentrations: ≥0.01 IU/mL and ≥0.10 IU/mL (measured by ELISA); 4. For anti-IPV1, anti-IPV2, and anti-IPV3 Abs - Response defined as a titer ≥ 8 (measured by MIT). The percentage of participants considered as responding to the individual antigen (per the response threshold\[s\]) were assessed.
Time frame: Month 5 (one month after receiving Vaccination 3)
Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3) | Anti-PRP Ab ≥ 1 μg/mL | 95.3 Percentage of Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3) | Anti-Diptheria Ab ≥0.01 IU/mL | 100.0 Percentage of Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3) | Anti-Diptheria Ab ≥0.10 IU/mL | 92.2 Percentage of Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3) | Anti-Tetanus ≥0.01 IU/mL | 100.0 Percentage of Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3) | Anti-Tetanus Ab ≥0.10 IU/mL | 100.0 Percentage of Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3) | Anti-IPV1 Ab Titer ≥8 | 100.0 Percentage of Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3) | Anti-IPV2 Ab Titer ≥8 | 100.0 Percentage of Participants |
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3) | Anti-IPV3 Ab Titer ≥8 | 100.0 Percentage of Participants |
Secondary
Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination
The percentage of participants with a body temperature ≥38.0°C from Day 1 to Day 5 after each vaccination was assessed. Per protocol, the participant's parent(s)/legal representative recorded daily body temperature measurements each evening by the axillary route (N=3 collected via rectal route; N=1 collected via oral route) and recorded these observations on the Vaccine Report Card (VRC). Temperatures were based on actual temperatures recorded with no adjustments for the route of assessment.
Time frame: Up to Day 5 following each vaccination
Population: All participants receiving ≥1 dose of any vaccination with corresponding safety follow-up data, having available body temperature data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination | 4.9 Percentage of Participants |
| Pediacel® (V2) | Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination | 6.3 Percentage of Participants |
| PR5I (V3) | Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination | 4.7 Percentage of Participants |
Secondary
Percentage of Participants With an Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibody Titer ≥8
The percentage of participants with an anti-MCC antibody titer ≥8 was assessed. Participant serum samples were collected and analyzed for anti-MCC antibodies with the Serum Bactericidal Antibody assay using rabbit complement (rSBA).
Time frame: Month 3 (one month after receiving Vaccination 2)
Population: All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PR5I (V1); Pediacel® (V2); PR5I (V3) | Percentage of Participants With an Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibody Titer ≥8 | 99.2 Percentage of Participants |