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This is a follow-up of Study A3L11 (NCT00404651).
Immunogenicity
Safety
- To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP~T.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Batch 1 | Experimental | Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651); and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. |
|
| DTaP-IPV-Hep B-PRP~T Batch 2 | Experimental | Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. |
|
| DTaP-IPV-Hep B-PRP~T Batch 3 | Experimental | Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. |
|
| Infanrix Hexaâ„¢ | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T vaccine (Batch 1) | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA. | Day 0 (pre-booster) and Day 30 (one month post-booster) |
| Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Antibody persistence and immunogenicity response: Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0. | Day 0 (pre-booster) and Day 30 (one month post-booster) |
| Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable. | Days 0 up to 7 after any injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Estado de México | Mexico | |||||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 881 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 25 March 2008 to 28 November 2008 at 5 clinical centers in Mexico.
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| ID | Title | Description |
|---|---|---|
| FG000 | DTaP-IPV-Hep B-PRP~T Batch 1 | Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix Hexaâ„¢) plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 (NCT00404651) and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. |
|
| DTaP-IPV-Hep B-PRP~T vaccine (Batch 2) | Biological | 0.5 mL, Intramuscular |
|
| DTaP-IPV-Hep B-PRP~T vaccine (Batch 3) | Biological | 0.5 mL, Intramuscular |
|
| Infanrix Hexaâ„¢ | Biological | 0.5 mL, Intramuscular |
|
| Insurgentes Cuicuilco |
| Mexico |
| Monterrey | Mexico |
| Puebla City | Mexico |
| FG001 | DTaP-IPV-Hep B-PRP~T Batch 2 | Participants had received 3 primary doses of Batch 2 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. |
| FG002 | DTaP-IPV-Hep B-PRP~T Batch 3 | Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. |
| FG003 | Infanrix Hexaâ„¢ | Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix hexaâ„¢), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study. |
| COMPLETED |
|
| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | DTaP-IPV-Hep B-PRP~T Batch 1 | Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. |
| BG001 | DTaP-IPV-Hep B-PRP~T Batch 2 | Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. |
| BG002 | DTaP-IPV-Hep B-PRP~T Batch 3 | Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. |
| BG003 | Infanrix Hexaâ„¢ | Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexaâ„¢), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA. | Geometric mean titers were assessed in a subset of participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-booster) and Day 30 (one month post-booster) |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Antibody persistence and immunogenicity response: Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0. | Antibody persistence and immunogenicity response were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per Protocol Population). | Posted | Number | Participants | Day 0 (pre-booster) and Day 30 (one month post-booster) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable. | Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). | Posted | Number | Participants | Days 0 up to 7 after any injection |
|
Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DTaP-IPV-Hep B-PRP~T Batch 1 | Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. | 1 | 254 | 188 | 254 | ||
| EG001 | DTaP-IPV-Hep B-PRP~T Batch 2 | Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. | 1 | 262 | 207 | 262 | ||
| EG002 | DTaP-IPV-Hep B-PRP~T Batch 3 | Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. | 1 | 252 | 197 | 252 | ||
| EG003 | Infanrix Hexaâ„¢ | Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexaâ„¢), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study. | 0 | 113 | 92 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Solicited Injection Site Erythema | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Solicited Injection Site Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Solicited Injection Site Swelling | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Crying | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D006509 | Hepatitis B |
| D011051 | Poliomyelitis |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D016871 | Pasteurellaceae Infections |
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| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Anti Hep B Post-booster (N = 58, 61, 58, 65) |
|
| Anti PRP Pre-booster (N = 58, 60, 57, 65) |
|
| Anti PRP Post-booster (N = 58, 61, 58, 65) |
|
| Anti Diphtheria Pre-booster (N = 58, 60, 57, 64) |
|
| Anti Diphtheria Post-booster (N = 58, 61, 58, 65) |
|
| Anti Tetanus Pre-booster (N = 58, 60, 57, 65) |
|
| Anti Tetanus Post-booster (N = 58, 61, 58, 65) |
|
| Anti Polio 1 Pre-booster (N = 57, 59, 57, 65) |
|
| Anti Polio 1 Post-booster (N = 57, 61, 58, 64) |
|
| Anti Polio 2 Pre-booster (N = 58, 59, 56, 65) |
|
| Anti Polio 2 Post-booster (N = 56, 61, 58, 64) |
|
| Anti Polio 3 Pre-booster (N = 58, 59, 56, 65) |
|
| Anti Polio 3 Post-booster (N = 56, 60, 58, 64) |
|
| Anti PT Pre-booster (N = 57, 59, 55, 64) |
|
| Anti PT Post-booster (N = 58, 61, 58, 64) |
|
| Anti FHA Pre-booster (N = 58, 60, 56, 64) |
|
| Anti FHA Post-booster (N = 58, 60, 58, 65) |
|
| OG002 | DTaP-IPV-Hep B-PRP~T Batch 3 | Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. |
| OG003 | Infanrix Hexaâ„¢ | Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexaâ„¢), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study. |
|
|
| OG002 | DTaP-IPV-Hep B-PRP~T Batch 3 | Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. |
| OG003 | Infanrix Hexaâ„¢ | Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexaâ„¢), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study. |
|
|