A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants

Lot-to-Lot Consistency Study of DTaP-IPV-Hep B-PRP-T Vaccine Administered at 2-4-6 Months of Age in Healthy Latin American Infants Concomitantly With Prevenar™ and Rotarix™

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01177722

Enrollment

1375

Registered

2010-08-09

Start date

2010-08-31

Completion date

2011-12-31

Last updated

2014-05-05

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

Conditions

Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough

Keywords

Diphtheria, Tetanus, Whooping cough, Hepatitis B, Poliomyelitis, Diphtheria-Tetanus-acellular Pertussis Vaccines

Brief summary

The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™ vaccines. Primary Objectives: * To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with Prevenar™ and Rotarix™, in terms of immunoresponses. * To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™. Secondary Objectives: * To describe in each group the immunogenicity parameters for all antigens for each vaccine * To assess the safety profile in terms of solicited and unsolicited adverse events and serious adverse events in each group for each vaccine.

Detailed description

Each participant will receive 3 doses of 1 of 3 lots of the investigational hexavalent vaccine or the control vaccine, Infanrix hexa™, administered with Prevenar™ at 2, 4, and 6 months of age and Rotarix™ at 2 and 4 months of age. All participants will be monitored for safety for 6 months after the last injection of the primary vaccination series.

Interventions

BIOLOGICALDTaP-IPV-Hep B-PRP-T Vaccine

0.5 mL, Intramuscular

BIOLOGICALDTaP-Hep B-IPV vaccine

0.5 mL, Intramuscular

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Days to 65 Days

Healthy volunteers

Yes

Inclusion criteria

: * Two month old infants (55 to 65 days old) on the day of inclusion. * Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg. * Informed consent form signed by one or both parents or by the legally acceptable representative as per local requirements. * Able to attend all scheduled visits and to comply with all trial procedures. * Received Hepatitis B and Bacille de Calmette-Guérin (BCG) vaccines between birth and one month of life in agreement with the national immunization calendar.

Exclusion criteria

: * Participation in another clinical trial in the 4 weeks preceding the first trial vaccination. * Planned participation in another clinical trial during the present trial period. * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy, or long-term systemic corticosteroid therapy. * Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances. * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. * Blood or blood-derived products received since birth that might interfere with the assessment of the immune response. * Any vaccination before trial vaccination (except Hepatitis B and Bacille de Calmette Guérin given at birth). * Any planned vaccination until 1 month after the last trial vaccination (except the study vaccines, rotavirus and pneumococcal conjugated vaccines). * Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or Hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically). * Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infections. * Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C seropositivity. * Known coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion contraindicating intramuscular (IM) vaccination. * History of seizures or encephalopathy. * Febrile illness (temperature ≥ 38.0°C), or moderate or severe acute illness/infection on the day of inclusion, according to the Investigator judgment.

Design outcomes

Primary

Measure	Time frame	Description
Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™	Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination	Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.
Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	30 Days post-dose 3	Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).

Secondary

Measure	Time frame	Description
Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Day 0 (pre-vaccination) and 30 days post-dose 3	Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP).
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Day 0 up to 7 after each dose	Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Day 0 up to 7 post each vaccination	Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.

Countries

Colombia, Costa Rica

Participant flow

Recruitment details

Participants were enrolled from 03 August 2010 to 23 November 2010 in 2 clinical centers in Columbia and 1 clinical center in Costa Rica.

Pre-assignment details

A total of 1375 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

Participants by arm

Arm	Count
DTap-IPV-Hep B-PRP~T Batch A Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\ T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	344
DTaP-IPV-Hep B-PRP~T Batch B Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\ T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	344
DTaP-IPV-Hep B-PRP~T Batch C Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine \[polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\ T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	342
Infanrix Hexa Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.	345
Total	1,375

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Lost to Follow-up	3	4	3	1
Overall Study	Protocol Violation	0	0	1	0
Overall Study	Serious Adverse Event	0	0	1	0
Overall Study	Withdrawal by Subject	10	6	4	6

Baseline characteristics

Characteristic	DTap-IPV-Hep B-PRP~T Batch A	DTaP-IPV-Hep B-PRP~T Batch B	DTaP-IPV-Hep B-PRP~T Batch C	Infanrix Hexa	Total
Age, Categorical <=18 years	344 Participants	344 Participants	342 Participants	345 Participants	1375 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Continuous	58.8 Days STANDARD_DEVIATION 3.49	58.7 Days STANDARD_DEVIATION 3.25	58.5 Days STANDARD_DEVIATION 3.16	58.7 Days STANDARD_DEVIATION 3.31	58.7 Days STANDARD_DEVIATION 3.3
Region of Enrollment Colombia	233 Participants	234 Participants	233 Participants	233 Participants	933 Participants
Region of Enrollment Costa Rica	111 Participants	110 Participants	109 Participants	112 Participants	442 Participants
Sex: Female, Male Female	161 Participants	165 Participants	152 Participants	156 Participants	634 Participants
Sex: Female, Male Male	183 Participants	179 Participants	190 Participants	189 Participants	741 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	208 / 345	206 / 343	216 / 342	193 / 345
serious Total, serious adverse events	10 / 345	14 / 343	16 / 342	10 / 345

Outcome results

Primary

Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™

Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.

Time frame: Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination

Population: GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per-Protocol Population).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
DTap-IPV-Hep B-PRP~T Batch A	Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™	Anti-Hep B Pre-dose 1	4.02 Titers
DTap-IPV-Hep B-PRP~T Batch A	Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™	Anti-Hep B Post-dose 3	3048 Titers
DTaP-IPV-Hep B-PRP~T Batch B	Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™	Anti-Hep B Post-dose 3	2801 Titers
DTaP-IPV-Hep B-PRP~T Batch B	Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™	Anti-Hep B Pre-dose 1	4.07 Titers
DTaP-IPV-Hep B-PRP~T Batch C	Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™	Anti-Hep B Post-dose 3	3202 Titers
DTaP-IPV-Hep B-PRP~T Batch C	Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™	Anti-Hep B Pre-dose 1	4.93 Titers
Infanrix Hexa	Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™	Anti-Hep B Post-dose 3	2766 Titers
Infanrix Hexa	Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™	Anti-Hep B Pre-dose 1	4.30 Titers

Primary

Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine

Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).

Time frame: 30 Days post-dose 3

Population: Seroprotection and vaccine response were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).

Arm	Measure	Group	Value (NUMBER)
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 2 (N = 309, 309, 307, 312)	309 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Tetanus (N = 311, 310, 311, 314)	311 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PRP (N = 312, 310, 312, 316)	299 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Diphtheria (N = 310, 310, 312, 315)	310 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Hep B (N = 312, 310, 312, 316)	311 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-FHA (N = 306, 306, 304, 311)	306 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 1 (N = 310, 309, 308, 311)	310 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 3 (N = 310, 309, 307, 312)	310 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PT (N = 308, 309, 308, 312)	304 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Diphtheria (N = 310, 310, 312, 315)	310 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PT (N = 308, 309, 308, 312)	299 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 1 (N = 310, 309, 308, 311)	309 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 2 (N = 309, 309, 307, 312)	309 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 3 (N = 310, 309, 307, 312)	309 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Hep B (N = 312, 310, 312, 316)	310 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Tetanus (N = 311, 310, 311, 314)	310 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-FHA (N = 306, 306, 304, 311)	305 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PRP (N = 312, 310, 312, 316)	298 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 2 (N = 309, 309, 307, 312)	307 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 1 (N = 310, 309, 308, 311)	308 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Tetanus (N = 311, 310, 311, 314)	311 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Diphtheria (N = 310, 310, 312, 315)	312 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PT (N = 308, 309, 308, 312)	299 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PRP (N = 312, 310, 312, 316)	287 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-FHA (N = 306, 306, 304, 311)	303 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Hep B (N = 312, 310, 312, 316)	310 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 3 (N = 310, 309, 307, 312)	307 Participants
Infanrix Hexa	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PRP (N = 312, 310, 312, 316)	303 Participants
Infanrix Hexa	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Tetanus (N = 311, 310, 311, 314)	314 Participants
Infanrix Hexa	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PT (N = 308, 309, 308, 312)	307 Participants
Infanrix Hexa	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-FHA (N = 306, 306, 304, 311)	309 Participants
Infanrix Hexa	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 1 (N = 310, 309, 308, 311)	311 Participants
Infanrix Hexa	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 2 (N = 309, 309, 307, 312)	312 Participants
Infanrix Hexa	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Diphtheria (N = 310, 310, 312, 315)	315 Participants
Infanrix Hexa	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 3 (N = 310, 309, 307, 312)	311 Participants
Infanrix Hexa	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Hep B (N = 312, 310, 312, 316)	316 Participants

Secondary

Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine

Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP).

Time frame: Day 0 (pre-vaccination) and 30 days post-dose 3

Population: GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
DTap-IPV-Hep B-PRP~T Batch A	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PT Post-dose 3 (N = 312, 310, 311, 314)	102 Titers
DTap-IPV-Hep B-PRP~T Batch A	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PRP Post-dose 3 (N = 312, 310, 312, 316)	3.37 Titers
DTap-IPV-Hep B-PRP~T Batch A	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-FHA Post-dose 3 (N=311, 309, 310, 315)	186 Titers
DTap-IPV-Hep B-PRP~T Batch A	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-FHA Pre-dose 1(N = 307, 307, 307, 312)	5.36 Titers
DTap-IPV-Hep B-PRP~T Batch A	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Tetanus Post-dose 3 (N = 311, 310, 311, 314)	1.66 Titers
DTap-IPV-Hep B-PRP~T Batch A	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Diphtheria Post-dose 3 (N=310, 310, 312, 315)	0.252 Titers
DTap-IPV-Hep B-PRP~T Batch A	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Diphtheria Pre-dose 1 (N= 312, 308, 311, 315)	0.599 Titers
DTap-IPV-Hep B-PRP~T Batch A	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PT Pre-dose 1 (N = 308, 309, 310, 314)	3.02 Titers
DTap-IPV-Hep B-PRP~T Batch A	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 3 Post-dose 3 (N = 310, 309, 307, 312)	1102 Titers
DTap-IPV-Hep B-PRP~T Batch A	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 2 Post-dose 3 (N = 309, 309, 307, 312)	1190 Titers
DTap-IPV-Hep B-PRP~T Batch A	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 1 Post-dose 3 (N = 310, 309, 308, 311)	755 Titers
DTaP-IPV-Hep B-PRP~T Batch B	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 2 Post-dose 3 (N = 309, 309, 307, 312)	1232 Titers
DTaP-IPV-Hep B-PRP~T Batch B	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Diphtheria Post-dose 3 (N=310, 310, 312, 315)	0.279 Titers
DTaP-IPV-Hep B-PRP~T Batch B	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PT Pre-dose 1 (N = 308, 309, 310, 314)	3.50 Titers
DTaP-IPV-Hep B-PRP~T Batch B	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PT Post-dose 3 (N = 312, 310, 311, 314)	103 Titers
DTaP-IPV-Hep B-PRP~T Batch B	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-FHA Pre-dose 1(N = 307, 307, 307, 312)	5.66 Titers
DTaP-IPV-Hep B-PRP~T Batch B	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-FHA Post-dose 3 (N=311, 309, 310, 315)	175 Titers
DTaP-IPV-Hep B-PRP~T Batch B	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 1 Post-dose 3 (N = 310, 309, 308, 311)	655 Titers
DTaP-IPV-Hep B-PRP~T Batch B	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Diphtheria Pre-dose 1 (N= 312, 308, 311, 315)	0.596 Titers
DTaP-IPV-Hep B-PRP~T Batch B	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Tetanus Post-dose 3 (N = 311, 310, 311, 314)	1.55 Titers
DTaP-IPV-Hep B-PRP~T Batch B	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 3 Post-dose 3 (N = 310, 309, 307, 312)	1119 Titers
DTaP-IPV-Hep B-PRP~T Batch B	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PRP Post-dose 3 (N = 312, 310, 312, 316)	4.02 Titers
DTaP-IPV-Hep B-PRP~T Batch C	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Diphtheria Post-dose 3 (N=310, 310, 312, 315)	0.228 Titers
DTaP-IPV-Hep B-PRP~T Batch C	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 3 Post-dose 3 (N = 310, 309, 307, 312)	1097 Titers
DTaP-IPV-Hep B-PRP~T Batch C	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PRP Post-dose 3 (N = 312, 310, 312, 316)	3.33 Titers
DTaP-IPV-Hep B-PRP~T Batch C	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 2 Post-dose 3 (N = 309, 309, 307, 312)	1120 Titers
DTaP-IPV-Hep B-PRP~T Batch C	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 1 Post-dose 3 (N = 310, 309, 308, 311)	636 Titers
DTaP-IPV-Hep B-PRP~T Batch C	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-FHA Pre-dose 1(N = 307, 307, 307, 312)	5.76 Titers
DTaP-IPV-Hep B-PRP~T Batch C	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Diphtheria Pre-dose 1 (N= 312, 308, 311, 315)	0.641 Titers
DTaP-IPV-Hep B-PRP~T Batch C	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PT Post-dose 3 (N = 312, 310, 311, 314)	102 Titers
DTaP-IPV-Hep B-PRP~T Batch C	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Tetanus Post-dose 3 (N = 311, 310, 311, 314)	1.45 Titers
DTaP-IPV-Hep B-PRP~T Batch C	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-FHA Post-dose 3 (N=311, 309, 310, 315)	183 Titers
DTaP-IPV-Hep B-PRP~T Batch C	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PT Pre-dose 1 (N = 308, 309, 310, 314)	3.54 Titers
Infanrix Hexa	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-FHA Post-dose 3 (N=311, 309, 310, 315)	118 Titers
Infanrix Hexa	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 1 Post-dose 3 (N = 310, 309, 308, 311)	1298 Titers
Infanrix Hexa	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PRP Post-dose 3 (N = 312, 310, 312, 316)	2.24 Titers
Infanrix Hexa	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Tetanus Post-dose 3 (N = 311, 310, 311, 314)	1.80 Titers
Infanrix Hexa	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Diphtheria Post-dose 3 (N=310, 310, 312, 315)	0.240 Titers
Infanrix Hexa	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 3 Post-dose 3 (N = 310, 309, 307, 312)	1944 Titers
Infanrix Hexa	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PT Post-dose 3 (N = 312, 310, 311, 314)	98.9 Titers
Infanrix Hexa	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Polio 2 Post-dose 3 (N = 309, 309, 307, 312)	1981 Titers
Infanrix Hexa	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-FHA Pre-dose 1(N = 307, 307, 307, 312)	5.13 Titers
Infanrix Hexa	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-Diphtheria Pre-dose 1 (N= 312, 308, 311, 315)	0.630 Titers
Infanrix Hexa	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anti-PT Pre-dose 1 (N = 308, 309, 310, 314)	3.11 Titers

Secondary

Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine

Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.

Time frame: Day 0 up to 7 post each vaccination

Population: Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set).

Arm	Measure	Group	Value (NUMBER)
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Erythema Post-dose 2 (N=333, 337, 335, 340	1 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Erythema Post-dose 2 (N = 333, 337, 335, 340)	65 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Pain Post-dose 3 (N = 331, 331, 334, 337)	8 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Swelling Post-dose 3 (N=331, 331, 334, 337	0 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Erythema Post-dose 1 (N=338, 341, 340, 344	0 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Erythema Post-dose 1 (N = 338, 341, 340, 344)	47 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Swelling Post-dose 2 (N=333, 337, 335, 340	0 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Swelling Post-dose 2 (N = 333, 337, 335, 340)	32 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Pain Post-dose 2 (N = 333, 337, 335, 340)	160 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Pain Post-dose 1 (N = 338, 341, 340, 344)	171 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Swelling Post-dose 1 (N=338, 341, 340, 344	0 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Swelling Post-dose 1 (N = 338, 341, 340, 344)	34 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Pain Post-dose 2 (N = 333, 337, 335, 340)	14 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Swelling Post-dose 3 (N = 331, 331, 334, 337)	27 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Erythema Post-dose 3 (N=331, 331, 334, 337	1 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Erythema Post-dose 3 (N = 331, 331, 334, 337)	63 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Pain Post-dose 3 (N =331, 331, 334, 337)	146 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Pain Post-dose 1 (N = 338, 341, 340, 344)	15 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Pain Post-dose 2 (N = 333, 337, 335, 340)	183 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Pain Post-dose 1 (N = 338, 341, 340, 344)	173 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Pain Post-dose 1 (N = 338, 341, 340, 344)	15 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Pain Post-dose 2 (N = 333, 337, 335, 340)	17 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Pain Post-dose 3 (N =331, 331, 334, 337)	105 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Pain Post-dose 3 (N = 331, 331, 334, 337)	9 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Erythema Post-dose 1 (N = 338, 341, 340, 344)	48 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Erythema Post-dose 1 (N=338, 341, 340, 344	1 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Erythema Post-dose 2 (N = 333, 337, 335, 340)	55 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Erythema Post-dose 2 (N=333, 337, 335, 340	0 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Erythema Post-dose 3 (N = 331, 331, 334, 337)	57 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Erythema Post-dose 3 (N=331, 331, 334, 337	1 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Swelling Post-dose 1 (N = 338, 341, 340, 344)	21 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Swelling Post-dose 1 (N=338, 341, 340, 344	0 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Swelling Post-dose 2 (N = 333, 337, 335, 340)	28 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Swelling Post-dose 2 (N=333, 337, 335, 340	0 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Swelling Post-dose 3 (N = 331, 331, 334, 337)	29 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Swelling Post-dose 3 (N=331, 331, 334, 337	0 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Pain Post-dose 3 (N =331, 331, 334, 337)	146 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Erythema Post-dose 2 (N=333, 337, 335, 340	0 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Erythema Post-dose 3 (N = 331, 331, 334, 337)	69 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Pain Post-dose 2 (N = 333, 337, 335, 340)	16 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Swelling Post-dose 3 (N=331, 331, 334, 337	0 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Erythema Post-dose 3 (N=331, 331, 334, 337	0 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Swelling Post-dose 3 (N = 331, 331, 334, 337)	36 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Swelling Post-dose 1 (N = 338, 341, 340, 344)	33 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Pain Post-dose 2 (N = 333, 337, 335, 340)	180 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Swelling Post-dose 1 (N=338, 341, 340, 344	2 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Pain Post-dose 1 (N = 338, 341, 340, 344)	184 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Swelling Post-dose 2 (N = 333, 337, 335, 340)	36 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Pain Post-dose 1 (N = 338, 341, 340, 344)	16 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Erythema Post-dose 1 (N = 338, 341, 340, 344)	55 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Pain Post-dose 3 (N = 331, 331, 334, 337)	10 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Erythema Post-dose 1 (N=338, 341, 340, 344	2 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Swelling Post-dose 2 (N=333, 337, 335, 340	1 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Erythema Post-dose 2 (N = 333, 337, 335, 340)	62 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Erythema Post-dose 1 (N = 338, 341, 340, 344)	42 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Swelling Post-dose 2 (N=333, 337, 335, 340	0 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Swelling Post-dose 1 (N=338, 341, 340, 344	1 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Erythema Post-dose 2 (N=333, 337, 335, 340	0 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Pain Post-dose 2 (N = 333, 337, 335, 340)	13 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Pain Post-dose 1 (N = 338, 341, 340, 344)	169 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Pain Post-dose 1 (N = 338, 341, 340, 344)	8 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Erythema Post-dose 3 (N = 331, 331, 334, 337)	49 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Pain Post-dose 3 (N =331, 331, 334, 337)	125 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Swelling Post-dose 3 (N=331, 331, 334, 337	0 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Swelling Post-dose 2 (N = 333, 337, 335, 340)	32 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Erythema Post-dose 3 (N=331, 331, 334, 337	0 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Pain Post-dose 2 (N = 333, 337, 335, 340)	174 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Pain Post-dose 3 (N = 331, 331, 334, 337)	7 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Erythema Post-dose 2 (N = 333, 337, 335, 340)	53 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Swelling Post-dose 1 (N = 338, 341, 340, 344)	31 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Grade 3 Erythema Post-dose 1 (N=338, 341, 340, 344	0 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine	Swelling Post-dose 3 (N = 331, 331, 334, 337)	29 Participants

Secondary

Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine

Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.

Time frame: Day 0 up to 7 after each dose

Population: Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set).

Arm	Measure	Group	Value (NUMBER)
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pyrexia Post dose 1 (N = 338, 341, 340, 344)	46 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Erythema Post-dose 3 (N = 331, 331, 334, 337)	85 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pain Post-dose 2 (N = 333, 337, 335, 340)	180 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Swelling post-dose 3(N=331, 331, 340, 338)	0 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Swelling Post-dose 1(N=338, 341, 340, 344)	2 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Swelling Post dose 3 (N = 331, 331, 334, 337)	43 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Swelling Post dose 2 (N = 333, 337, 335, 340)	44 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Vomiting Post dose 3 (N = 331, 331, 334, 337)	32 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Anorexia Post-dose 3(N=331, 331, 334, 337)	4 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Swelling Post dose 1 (N = 338, 341, 340, 344)	47 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Erythema Post-dose 3(N=331, 331, 334, 337)	0 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Vomiting Post-dose 1(N=338, 341, 340, 344)	4 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Crying Post dose 3 (N = 331, 331, 334, 337)	141 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Crying Post dose 2 (N = 333, 337, 335, 340)	163 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Anorexia Post-dose 1(N=338, 341, 341, 344)	3 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Crying Post dose 1 (N = 338, 341, 340, 344)	198 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Erythema Post-dose 1(N=338, 341, 340, 344)	2 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pyrexia Post-dose 3 (N=331, 331, 333, 337)	4 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anorexia Post dose 3 (N = 331, 331, 334, 337)	63 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grd 3 Irritability Post-dose 1N=338, 341, 341, 344	15 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anorexia Post dose 2 (N = 333, 337, 335, 340)	75 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anorexia Post dose 1 (N = 338, 341, 341, 344)	78 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pain Post-dose 1 (N = 338, 341, 340, 344)	199 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pyrexia Post-dose 1 (N=338, 341, 340, 344)	2 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Irritability Post dose 3 (N = 331, 332, 334, 337)	155 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Vomiting post-dose 3(N=331, 331, 334, 337)	3 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grad 3 Somnolence Post-dose 3 N=331, 331, 334, 337	5 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grad 3 Somnolence Post-dose 1 N=338, 341, 341, 344	3 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Vomiting Post dose 1 (N = 338, 341, 340, 344)	85 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pain Post-dose 3 (N = 331, 331, 334, 337)	168 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Somnolence Post dose 3 (N = 331, 331, 334, 337)	85 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Somnolence Post dose 2 (N = 333, 337, 335, 340)	109 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Vomiting Post dose 2 (N = 333, 337, 335, 340)	58 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grd 3 Irritability Post-dose 3N=331, 332, 334, 337	11 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Irritability Post dose 2 (N = 333, 337, 335, 340)	193 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Somnolence Post dose 1 (N = 338, 341, 341, 344)	159 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Crying Post-dose 3 (N =331, 331, 334, 337)	8 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pain Post Dose 3 (N=331, 331, 334, 338)	10 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Irritability Post dose 1 (N = 338, 341, 341, 344)	208 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Crying Post-dose 1 (N =338, 341, 340, 344)	15 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pyrexia Post dose 3 (N = 331, 331, 333, 337)	67 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Erythema Post-dose 1 (N = 338, 341, 340, 344	72 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Erythema Post-dose 2 (N = 333, 337, 335, 340	87 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pain Post Dose 1 (N = 338, 341, 344, 344)	21 Participants
DTap-IPV-Hep B-PRP~T Batch A	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pyrexia Post dose 2 (N = 333, 337, 335, 340)	70 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pyrexia Post dose 2 (N = 333, 337, 335, 340)	68 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pain Post-dose 1 (N = 338, 341, 340, 344)	194 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pain Post-dose 2 (N = 333, 337, 335, 340)	196 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pain Post-dose 3 (N = 331, 331, 334, 337)	163 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Erythema Post-dose 1 (N = 338, 341, 340, 344	63 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Erythema Post-dose 1(N=338, 341, 340, 344)	3 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Swelling Post dose 1 (N = 338, 341, 340, 344)	30 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Vomiting Post-dose 1(N=338, 341, 340, 344)	5 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Vomiting Post dose 1 (N = 338, 341, 340, 344)	90 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Vomiting Post dose 2 (N = 333, 337, 335, 340)	80 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pain Post Dose 1 (N = 338, 341, 344, 344)	22 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pain Post Dose 3 (N=331, 331, 334, 338)	9 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Erythema Post-dose 2 (N = 333, 337, 335, 340	78 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Erythema Post-dose 3 (N = 331, 331, 334, 337)	79 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Vomiting Post dose 3 (N = 331, 331, 334, 337)	58 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Vomiting post-dose 3(N=331, 331, 334, 337)	1 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Crying Post dose 1 (N = 338, 341, 340, 344)	186 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Crying Post dose 2 (N = 333, 337, 335, 340)	179 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Crying Post dose 3 (N = 331, 331, 334, 337)	145 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Erythema Post-dose 3(N=331, 331, 334, 337)	0 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Swelling Post dose 2 (N = 333, 337, 335, 340)	35 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Swelling Post dose 3 (N = 331, 331, 334, 337)	34 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Swelling Post-dose 1(N=338, 341, 340, 344)	3 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Swelling post-dose 3(N=331, 331, 340, 338)	0 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pyrexia Post dose 1 (N = 338, 341, 340, 344)	42 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pyrexia Post dose 3 (N = 331, 331, 333, 337)	63 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Crying Post-dose 1 (N =338, 341, 340, 344)	10 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Crying Post-dose 3 (N =331, 331, 334, 337)	6 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Somnolence Post dose 1 (N = 338, 341, 341, 344)	146 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Somnolence Post dose 2 (N = 333, 337, 335, 340)	108 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Somnolence Post dose 3 (N = 331, 331, 334, 337)	99 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grad 3 Somnolence Post-dose 1 N=338, 341, 341, 344	14 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grad 3 Somnolence Post-dose 3 N=331, 331, 334, 337	2 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anorexia Post dose 1 (N = 338, 341, 341, 344)	97 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anorexia Post dose 2 (N = 333, 337, 335, 340)	93 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anorexia Post dose 3 (N = 331, 331, 334, 337)	64 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Anorexia Post-dose 1(N=338, 341, 341, 344)	4 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Anorexia Post-dose 3(N=331, 331, 334, 337)	7 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Irritability Post dose 1 (N = 338, 341, 341, 344)	206 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Irritability Post dose 2 (N = 333, 337, 335, 340)	199 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Irritability Post dose 3 (N = 331, 332, 334, 337)	161 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grd 3 Irritability Post-dose 1N=338, 341, 341, 344	17 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grd 3 Irritability Post-dose 3N=331, 332, 334, 337	13 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pyrexia Post-dose 1 (N=338, 341, 340, 344)	0 Participants
DTaP-IPV-Hep B-PRP~T Batch B	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pyrexia Post-dose 3 (N=331, 331, 333, 337)	1 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Swelling Post-dose 1(N=338, 341, 340, 344)	2 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Erythema Post-dose 3 (N = 331, 331, 334, 337)	96 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Swelling post-dose 3(N=331, 331, 340, 338)	0 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Irritability Post dose 2 (N = 333, 337, 335, 340)	191 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pyrexia Post dose 1 (N = 338, 341, 340, 344)	68 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Erythema Post-dose 2 (N = 333, 337, 335, 340	80 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pyrexia Post dose 2 (N = 333, 337, 335, 340)	68 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pain Post Dose 3 (N=331, 331, 334, 338)	8 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Crying Post-dose 1 (N =338, 341, 340, 344)	23 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pain Post-dose 1 (N = 338, 341, 340, 344)	216 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Crying Post-dose 3 (N =331, 331, 334, 337)	10 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pain Post Dose 1 (N = 338, 341, 344, 344)	22 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Irritability Post dose 3 (N = 331, 332, 334, 337)	154 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Somnolence Post dose 1 (N = 338, 341, 341, 344)	160 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Somnolence Post dose 2 (N = 333, 337, 335, 340)	110 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Vomiting Post dose 1 (N = 338, 341, 340, 344)	86 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pain Post-dose 2 (N = 333, 337, 335, 340)	203 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Somnolence Post dose 3 (N = 331, 331, 334, 337)	96 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pyrexia Post-dose 1 (N=338, 341, 340, 344)	0 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grad 3 Somnolence Post-dose 1 N=338, 341, 341, 344	19 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pyrexia Post-dose 3 (N=331, 331, 333, 337)	1 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grd 3 Irritability Post-dose 1N=338, 341, 341, 344	20 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grad 3 Somnolence Post-dose 3 N=331, 331, 334, 337	4 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anorexia Post dose 1 (N = 338, 341, 341, 344)	96 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Swelling Post dose 1 (N = 338, 341, 340, 344)	47 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anorexia Post dose 2 (N = 333, 337, 335, 340)	86 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Erythema Post-dose 1(N=338, 341, 340, 344)	2 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anorexia Post dose 3 (N = 331, 331, 334, 337)	60 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grd 3 Irritability Post-dose 3N=331, 332, 334, 337	12 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Anorexia Post-dose 1(N=338, 341, 341, 344)	8 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Erythema Post-dose 1 (N = 338, 341, 340, 344	82 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Vomiting post-dose 3(N=331, 331, 334, 337)	2 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Anorexia Post-dose 3(N=331, 331, 334, 337)	4 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Crying Post dose 1 (N = 338, 341, 340, 344)	189 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Crying Post dose 2 (N = 333, 337, 335, 340)	169 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Vomiting Post-dose 1(N=338, 341, 340, 344)	6 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Crying Post dose 3 (N = 331, 331, 334, 337)	142 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pyrexia Post dose 3 (N = 331, 331, 333, 337)	72 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Erythema Post-dose 3(N=331, 331, 334, 337)	1 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Vomiting Post dose 3 (N = 331, 331, 334, 337)	46 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Irritability Post dose 1 (N = 338, 341, 341, 344)	208 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Swelling Post dose 2 (N = 333, 337, 335, 340)	45 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Vomiting Post dose 2 (N = 333, 337, 335, 340)	64 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Swelling Post dose 3 (N = 331, 331, 334, 337)	48 Participants
DTaP-IPV-Hep B-PRP~T Batch C	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pain Post-dose 3 (N = 331, 331, 334, 337)	162 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Vomiting Post dose 2 (N = 333, 337, 335, 340)	62 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anorexia Post dose 1 (N = 338, 341, 341, 344)	75 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pyrexia Post dose 3 (N = 331, 331, 333, 337)	65 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Crying Post dose 2 (N = 333, 337, 335, 340)	161 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Swelling post-dose 3(N=331, 331, 340, 338)	0 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Erythema Post-dose 2 (N = 333, 337, 335, 340	67 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pain Post-dose 1 (N = 338, 341, 340, 344)	185 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Swelling Post-dose 1(N=338, 341, 340, 344)	0 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pyrexia Post dose 1 (N = 338, 341, 340, 344)	46 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anorexia Post dose 2 (N = 333, 337, 335, 340)	74 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pain Post-dose 3 (N = 331, 331, 334, 337)	147 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pyrexia Post dose 2 (N = 333, 337, 335, 340)	70 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pain Post Dose 3 (N=331, 331, 334, 338)	8 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Irritability Post dose 2 (N = 333, 337, 335, 340)	193 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Crying Post dose 3 (N = 331, 331, 334, 337)	120 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pyrexia Post-dose 1 (N=338, 341, 340, 344)	0 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Pain Post-dose 2 (N = 333, 337, 335, 340)	188 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Swelling Post dose 3 (N = 331, 331, 334, 337)	42 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Crying Post-dose 1 (N =338, 341, 340, 344)	9 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pain Post Dose 1 (N = 338, 341, 344, 344)	7 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Anorexia Post dose 3 (N = 331, 331, 334, 337)	54 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Erythema Post-dose 1 (N = 338, 341, 340, 344	52 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Crying Post-dose 3 (N =331, 331, 334, 337)	6 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Erythema Post-dose 1(N=338, 341, 340, 344)	0 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Vomiting Post dose 3 (N = 331, 331, 334, 337)	39 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Anorexia Post-dose 1(N=338, 341, 341, 344)	3 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Somnolence Post dose 1 (N = 338, 341, 341, 344)	147 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Vomiting Post dose 1 (N = 338, 341, 340, 344)	94 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Irritability Post dose 3 (N = 331, 332, 334, 337)	144 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Swelling Post dose 2 (N = 333, 337, 335, 340)	44 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Somnolence Post dose 2 (N = 333, 337, 335, 340)	111 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grd 3 Irritability Post-dose 3N=331, 332, 334, 337	5 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Vomiting post-dose 3(N=331, 331, 334, 337)	2 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Erythema Post-dose 3 (N = 331, 331, 334, 337)	68 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Somnolence Post dose 3 (N = 331, 331, 334, 337)	81 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Pyrexia Post-dose 3 (N=331, 331, 333, 337)	2 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Erythema Post-dose 3(N=331, 331, 334, 337)	0 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Irritability Post dose 1 (N = 338, 341, 341, 344)	180 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grad 3 Somnolence Post-dose 1 N=338, 341, 341, 344	9 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Crying Post dose 1 (N = 338, 341, 340, 344)	161 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Vomiting Post-dose 1(N=338, 341, 340, 344)	5 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grade 3 Anorexia Post-dose 3(N=331, 331, 334, 337)	3 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grad 3 Somnolence Post-dose 3 N=331, 331, 334, 337	4 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Swelling Post dose 1 (N = 338, 341, 340, 344)	33 Participants
Infanrix Hexa	Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	Grd 3 Irritability Post-dose 1N=338, 341, 341, 344	8 Participants

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026

A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants

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Detailed description

Related papers

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Study design

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Outcome results

Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™

Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine

Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine

Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine

Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine