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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
385
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.
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.
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.
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.
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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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)
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