Infections, Streptococcal
Conditions
Keywords
Human Immunodeficiency Virus, Booster vaccination, Safety, Primary vaccination, Pneumococcal vaccine, Immunogenicity, Pneumococcal disease
Brief summary
The purposes of this study: * To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants following a 3-dose primary vaccination at 6, 10 and 14 weeks of age and following booster vaccination at 9-10 months of age. * To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV unexposed uninfected infants receiving either a 3-dose primary vaccination according to the EPI vaccination schedule at 6, 10 and 14 weeks of age with or without booster vaccination at 9-10 months of age or a 2-dose primary vaccination at 6 and 14 weeks of age followed by booster vaccination at 9-10 months of age. * This study also aims to assess the impact of the pneumococcal vaccine GSK1024850A on nasopharyngeal carriage of S. pneumoniae and H. influenzae up to 24 months of age in all study participants.
Detailed description
This protocol posting has been updated according to Protocol amendment 1, December 08
Interventions
BIOLOGICALPneumococcal vaccine GSK1024850A
Intramuscular injection, administered as 3 or 4 doses
BIOLOGICALTritanrix-HepB/Hib
Intramuscular injection, 4 doses
BIOLOGICALmeasles
Intramuscular injection, 2 doses
BIOLOGICALRotarix
Oral, 2 doses
BIOLOGICALLocal OPV
Oral 4 doses. Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 10 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination. * Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol. * Written informed consent obtained from the parent(s)/guardian(s) of the child/ward. * Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period. * A family history of hereditary immunodeficiency other than HIV infection. * Major congenital defects or serious chronic illness other than HIV infection. * For HIV infected infants: Moderately and severely symptomatic: stages III and IV according to latest version of WHO classification. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and/or Streptococcus pneumoniae. * History of, or intercurrent, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b disease. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * History of any neurological disorders or seizures. * Acute disease at the time of enrolment. * Babies for which weight for age is \< 3rd percentile at Visit 1, using standard growth charts, with the exception of HIV infected infants for which the decision of enrolment was left to the investigator's discretion. * Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator. * Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of vaccination).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | 1 month following primary immunization (post-Dose 3 at Month 3 for the HIV+/+ Group, HIV+/- Group, HIV- (3+1) Group, HIV- (3+0) Group and post-Dose 2 at Month 3 for the HIV- (2+1) Group) | Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | At Month 3 and at Month 9 | Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8. |
| Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | At Month 3 and Month 9 | Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. The cut-off of the assay is 0.05 µg/mL. |
| Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | At Month 3 and at Month 9 | Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8. |
| Concentrations of Antibodies Against Protein D (PD) by ELISA | At Month 3 and at Month 9 | Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay was 100 EL.U/mL. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. |
| Concentrations of Antibodies Against Protein D (PD) by ELISA. | up to study end at Month 23 (24-27 months of age) | Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay was 100 EL.U/mL. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. |
| Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | 1 month following primary immunization (at Month 3) | Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL) The cut-off of the assay is 0.1IU/mL. |
| Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA. | 1 month following primary immunization (at Month 3) | Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 15 EL.U/mL. |
| Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA . | 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15) | Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 15 EL.U/mL. |
| Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP) | 1 month following primary immunization (at Month 3) | Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL). The cut-off of the assay is 0.15 µg/mL. |
| Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA | 1 month following primary immunization (at Month 3) | Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay is 10 mIU/mL. As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis |
| Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | At Month 3 and Month 9 | Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups, post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. The cut-off of the assay is 0.05 µg/mL. |
| Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | 1 month after the administration of the second vaccine dose (at Month 3) | Concentrations of antibodies are presented as GMCs expressed as units per millilitre (U/mL). The cut-off of the assay is 20 U/mL. Data were collected for subjects who received 1, 2 doses or no Rotarix dose during the study. |
| Concentrations of Antibodies Against Measles | 1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15) | Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL).The cut-off of the assay is 150 mIU/mL. |
| Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | up to study end at Month 23 (24-27 months of age) | Salivary antibodies against selected common bacterial protein antigens. Salivary samples (1.0 mL) were collected by using an Oracol™ device consisting of a sponge (2 cm3) placed on a stick that was used to brush the teeth and gums to absorb the saliva. Salivary samples were sent to RMPRU (or GSK Biologicals' designated validated laboratory) where the sponge was centrifuged to extract the saliva and that was immediately stored at -70°C. The cut-off of the assay was 2.3 U/mL for anti-LytC IgA and 2.2 U/mL for anti PhtD IgA. |
| Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | up to study end at Month 23 (24-27 months of age) | Positive cultures of H. influenza\* (HI) and S. pneumonia(SP) and other bacterial pathogens such as Moraxella catarrhalis(MC), Group A streptococci and Staphylococcus aureus (SA), identified in the nasopharynx at each swab time point: Month (Mth) 0 (Pre-vaccination time point at 6-12 weeks of age), Mth 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age). \*Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay |
| Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | up to study end at Month 23 (24-27 months of age) | Acquisition of new H. influenza\* (HI) and S. pneumonia(SP) strains, identified in the nasopharynx at each swab time point: Month (Mth) 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age). \*Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by PCR assay |
| Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | During the 4-day (Days 0-3) post-primary vaccination period across doses | Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. |
| Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | During the 4-day (Days 0-3) post-primary vaccination period across doses | General AEs = diarrhoea, drowsiness, irritability, loss of appetite, vomiting and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. diarrhoea: ≥ 6 looser than normal stools/day. vomiting: ≥ 3 episodes of vomiting/day. Fever = \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Unsolicited AEs. | Within the 31-day (Days 0-30) post-primary vaccination period | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects With Serious Adverse Events (SAEs). | From study start at Month 0 (6 weeks of age and above) up to study end at Month 23 (24-27 months of age) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. |
| Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA. | 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15) | Concentrations of antibodies were presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay was 10 mIU/mL. As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis |
Countries
South Africa
Participant flow
Recruitment details
The oral poliovirus vaccine could be given at any time during the study (routinely given concurrently with Tritanrix™-HepB/Hib vaccine) but was not considered as study vaccine. Out of the 489 subjects enrolled in the study, 484 subjects were assigned to a study group and received vaccination.
Pre-assignment details
The study included 3 populations defined based on the human immunodeficiency virus status of the mother and the infant. Infant born from: * a HIV positive mother and HIV infected at Month 0 = HIV+/+. * a HIV positive mother and HIV exposed uninfected at screening = HIV+/-. * a HIV negative mother and HIV unexposed uninfected at Month 0 = HIV-
Participants by arm
| Arm | Count |
|---|---|
| HIV+/+ Group Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as study vaccine. The Synflorix™ vaccine was administered intramuscularly (IM) in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally. | 83 |
| HIV+/- Group Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally. | 101 |
| HIV- (3+1) Group Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally. | 100 |
| HIV- (3+0) Group Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally. | 100 |
| HIV- (2+1) Group Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally. | 100 |
| Total | 484 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Fatality | 5 | 4 | 0 | 3 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 2 | 0 | 0 |
| Overall Study | Migrated/Moved from study area | 3 | 4 | 0 | 5 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | HIV+/+ Group | HIV+/- Group | HIV- (3+1) Group | HIV- (3+0) Group | HIV- (2+1) Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 6.6 Weeks STANDARD_DEVIATION 0.92 | 6.3 Weeks STANDARD_DEVIATION 0.65 | 6.1 Weeks STANDARD_DEVIATION 0.41 | 6.1 Weeks STANDARD_DEVIATION 0.35 | 6.1 Weeks STANDARD_DEVIATION 0.29 | 6.2 Weeks STANDARD_DEVIATION 0.59 |
| Sex: Female, Male Female | 49 Participants | 47 Participants | 58 Participants | 50 Participants | 47 Participants | 251 Participants |
| Sex: Female, Male Male | 34 Participants | 54 Participants | 42 Participants | 50 Participants | 53 Participants | 233 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 83 / 83 | 100 / 101 | 98 / 100 | 98 / 100 | 98 / 100 |
| serious Total, serious adverse events | 31 / 83 | 25 / 101 | 20 / 100 | 15 / 100 | 20 / 100 |
Outcome results
Primary
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: 1 month following primary immunization (post-Dose 3 at Month 3 for the HIV+/+ Group, HIV+/- Group, HIV- (3+1) Group, HIV- (3+0) Group and post-Dose 2 at Month 3 for the HIV- (2+1) Group)
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV+/+ Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-5 | 70 Participants |
| HIV+/+ Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-23F | 63 Participants |
| HIV+/+ Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-6B | 61 Participants |
| HIV+/+ Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-19F | 68 Participants |
| HIV+/+ Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-18C | 69 Participants |
| HIV+/+ Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-4 | 69 Participants |
| HIV+/+ Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-1 | 69 Participants |
| HIV+/+ Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-14 | 69 Participants |
| HIV+/+ Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-9V | 68 Participants |
| HIV+/+ Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-7F | 69 Participants |
| HIV+/- Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-4 | 90 Participants |
| HIV+/- Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-1 | 90 Participants |
| HIV+/- Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-5 | 90 Participants |
| HIV+/- Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-6B | 80 Participants |
| HIV+/- Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-7F | 90 Participants |
| HIV+/- Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-9V | 90 Participants |
| HIV+/- Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-14 | 90 Participants |
| HIV+/- Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-18C | 90 Participants |
| HIV+/- Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-19F | 90 Participants |
| HIV+/- Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-23F | 84 Participants |
| HIV- (3+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-9V | 93 Participants |
| HIV- (3+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-19F | 93 Participants |
| HIV- (3+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-5 | 93 Participants |
| HIV- (3+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-6B | 74 Participants |
| HIV- (3+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-4 | 93 Participants |
| HIV- (3+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-7F | 93 Participants |
| HIV- (3+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-14 | 93 Participants |
| HIV- (3+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-1 | 93 Participants |
| HIV- (3+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-23F | 83 Participants |
| HIV- (3+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-18C | 93 Participants |
| HIV- (3+0) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-4 | 93 Participants |
| HIV- (3+0) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-23F | 84 Participants |
| HIV- (3+0) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-1 | 94 Participants |
| HIV- (3+0) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-5 | 94 Participants |
| HIV- (3+0) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-9V | 94 Participants |
| HIV- (3+0) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-18C | 94 Participants |
| HIV- (3+0) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-19F | 93 Participants |
| HIV- (3+0) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-14 | 93 Participants |
| HIV- (3+0) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-6B | 83 Participants |
| HIV- (3+0) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-7F | 94 Participants |
| HIV- (2+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-6B | 80 Participants |
| HIV- (2+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-19F | 94 Participants |
| HIV- (2+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-7F | 96 Participants |
| HIV- (2+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-9V | 92 Participants |
| HIV- (2+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-23F | 84 Participants |
| HIV- (2+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-14 | 95 Participants |
| HIV- (2+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-1 | 96 Participants |
| HIV- (2+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-18C | 95 Participants |
| HIV- (2+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-5 | 95 Participants |
| HIV- (2+1) Group | Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). | Anti-4 | 96 Participants |
Secondary
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Salivary antibodies against selected common bacterial protein antigens. Salivary samples (1.0 mL) were collected by using an Oracol™ device consisting of a sponge (2 cm3) placed on a stick that was used to brush the teeth and gums to absorb the saliva. Salivary samples were sent to RMPRU (or GSK Biologicals' designated validated laboratory) where the sponge was centrifuged to extract the saliva and that was immediately stored at -70°C. The cut-off of the assay was 2.3 U/mL for anti-LytC IgA and 2.2 U/mL for anti PhtD IgA.
Time frame: up to study end at Month 23 (24-27 months of age)
Population: The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month11] | 37.01 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month3] | 18.30 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month8] | 27.23 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month9] | 30.96 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month0] | 7.71 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month14] | 39.45 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month15] | 58.11 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month23] | 89.32 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month0] | 4.58 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month3] | 5.49 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month8] | 7.77 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month9] | 9.16 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month11] | 9.49 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month14] | 14.06 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month15] | 15.04 U/mL |
| HIV+/+ Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month23] | 41.41 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month14] | 10.74 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month3] | 4.92 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month0] | 3.83 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month15] | 11.35 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month23] | 43.61 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month11] | 18.79 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month9] | 15.54 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month3] | 13.48 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month0] | 5.49 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month11] | 7.92 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month14] | 24.69 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month8] | 15.99 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month23] | 29.17 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month9] | 7.32 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month8] | 5.86 U/mL |
| HIV+/- Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month15] | 28.09 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month14] | 19.39 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month9] | 24.60 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month11] | 43.03 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month14] | 39.59 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month15] | 42.43 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month23] | 68.34 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month15] | 18.06 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month0] | 7.85 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month3] | 5.14 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month8] | 9.49 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month9] | 16.47 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month11] | 16.93 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month0] | 6.22 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month23] | 39.84 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month3] | 13.29 U/mL |
| HIV- (3+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month8] | 24.51 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month3] | 5.06 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month23] | 35.69 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month8] | 10.01 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month14] | 22.04 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month9] | 14.01 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month14] | 38.87 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month11] | 15.41 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month9] | 21.06 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month0] | 5.98 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month8] | 22.64 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month23] | 61.40 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month11] | 35.65 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month0] | 6.30 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month15] | 24.03 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month15] | 50.45 U/mL |
| HIV- (3+0) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month3] | 13.81 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month11] | 15.70 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month3] | 5.10 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month15] | 17.07 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month11] | 38.07 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month3] | 14.43 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month23] | 59.75 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month8] | 8.35 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month23] | 35.92 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month14] | 34.75 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month0] | 5.49 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month0] | 6.67 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month9] | 11.71 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month15] | 42.98 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-PhtD [Month14] | 14.54 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month9] | 25.00 U/mL |
| HIV- (2+1) Group | Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples | Anti-LytC [Month8] | 21.85 U/mL |
Secondary
Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA .
Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 15 EL.U/mL.
Time frame: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
Population: The ATP cohort for immunogenicityat 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA . | 161.01 EL.U/mL |
| HIV+/- Group | Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA . | 227.01 EL.U/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA . | 241.77 EL.U/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA . | 259.45 EL.U/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA . | 267.80 EL.U/mL |
Secondary
Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA.
Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 15 EL.U/mL.
Time frame: 1 month following primary immunization (at Month 3)
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA. | 90.86 EL.U/mL |
| HIV+/- Group | Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA. | 132.27 EL.U/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA. | 143.08 EL.U/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA. | 152.23 EL.U/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA. | 146.60 EL.U/mL |
Secondary
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. The cut-off of the assay is 0.05 µg/mL.
Time frame: At Month 3 and Month 9
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A [Month 3] | 0.15 µg/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A [Month 3] | 0.16 µg/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A [Month 9] | 0.99 µg/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A [Month 9] | 0.48 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A [Month 9] | 1.48 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A [Month 3] | 0.12 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A [Month 3] | 0.28 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A [Month 9] | 0.58 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A [Month 3] | 0.12 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A [Month 9] | 0.78 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A [Month 3] | 0.20 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A [Month 9] | 0.36 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A [Month 3] | 0.13 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A [Month 9] | 0.26 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A [Month 3] | 0.29 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A [Month 9] | 0.21 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A [Month 3] | 0.11 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A [Month 9] | 1.04 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A [Month 9] | 0.36 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A [Month 3] | 0.25 µg/mL |
Secondary
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. The cut-off of the assay is 0.05 µg/mL.
Time frame: up to study end at Month 23 (24-27 months of age)
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A | 0.23 µg/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A | 0.45 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A | 0.25 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A | 0.47 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A | 0.20 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A | 0.53 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A | 0.41 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A | 0.25 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-6A | 0.19 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Anti-19A | 0.58 µg/mL |
Secondary
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).
Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL). The cut-off of the assay is 0.1IU/mL.
Time frame: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
Population: The According-To-Protocol cohort for immunogenicity at 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-DT | 9.57 IU/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-TT | 14.44 IU/mL |
| HIV+/- Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-DT | 11.70 IU/mL |
| HIV+/- Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-TT | 14.60 IU/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-DT | 10.45 IU/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-TT | 16.19 IU/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-TT | 17.69 IU/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-DT | 12.67 IU/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-DT | 11.96 IU/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-TT | 19.77 IU/mL |
Secondary
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).
Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL) The cut-off of the assay is 0.1IU/mL.
Time frame: 1 month following primary immunization (at Month 3)
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-DT | 2.42 IU/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-TT | 5.03 IU/mL |
| HIV+/- Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-DT | 3.69 IU/mL |
| HIV+/- Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-TT | 4.77 IU/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-DT | 3.42 IU/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-TT | 4.50 IU/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-TT | 5.03 IU/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-DT | 4.20 IU/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-DT | 3.00 IU/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). | Anti-TT | 4.24 IU/mL |
Secondary
Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA
Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay is 10 mIU/mL. As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis
Time frame: 1 month following primary immunization (at Month 3)
Population: According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA | 288.45 mIU/mL |
| HIV+/- Group | Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA | 478.53 mIU/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA | 865.5 mIU/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA | 904.7 mIU/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA | 563.5 mIU/mL |
Secondary
Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA.
Concentrations of antibodies were presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay was 10 mIU/mL. As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis
Time frame: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
Population: The ATP cohort for immunogenicity at 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA. | 1871.0 mIU/mL |
| HIV+/- Group | Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA. | 2507.4 mIU/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA. | 3674.4 mIU/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA. | 4287.6 mIU/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA. | 3583.4 mIU/mL |
Secondary
Concentrations of Antibodies Against Measles
Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL).The cut-off of the assay is 150 mIU/mL.
Time frame: 1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15)
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Measles | Anti-Measles [Month 9] | 2013.36 mIU/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Measles | Anti-Measles [Month 15] | 3358.15 mIU/mL |
| HIV+/- Group | Concentrations of Antibodies Against Measles | Anti-Measles [Month 9] | 1917.14 mIU/mL |
| HIV+/- Group | Concentrations of Antibodies Against Measles | Anti-Measles [Month 15] | 4189.83 mIU/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Measles | Anti-Measles [Month 9] | 1973.84 mIU/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Measles | Anti-Measles [Month 15] | 3713.51 mIU/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Measles | Anti-Measles [Month 15] | 3311.30 mIU/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Measles | Anti-Measles [Month 9] | 1509.36 mIU/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Measles | Anti-Measles [Month 9] | 1719.76 mIU/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Measles | Anti-Measles [Month 15] | 3204.79 mIU/mL |
Secondary
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)
Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL). The cut-off of the assay is 0.15 µg/mL.
Time frame: 1 month after the booster vaccination (at Month 15)
Population: The ATP cohort for immunogenicity at 15 -18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP) | 50.11 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP) | 71.23 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP) | 83.46 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP) | 93.18 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP) | 129.99 µg/mL |
Secondary
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)
Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL). The cut-off of the assay is 0.15 µg/mL.
Time frame: 1 month following primary immunization (at Month 3)
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP) | 16.71 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP) | 20.55 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP) | 20.36 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP) | 24.22 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP) | 21.78 µg/mL |
Secondary
Concentrations of Antibodies Against Protein D (PD) by ELISA
Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay was 100 EL.U/mL. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.
Time frame: At Month 3 and at Month 9
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Protein D (PD) by ELISA | Anti-PD [Month 3] | 4215.1 EL.U/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Protein D (PD) by ELISA | Anti-PD [Month 9] | 5443.1 EL.U/mL |
| HIV+/- Group | Concentrations of Antibodies Against Protein D (PD) by ELISA | Anti-PD [Month 3] | 3397.6 EL.U/mL |
| HIV+/- Group | Concentrations of Antibodies Against Protein D (PD) by ELISA | Anti-PD [Month 9] | 5018.3 EL.U/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Protein D (PD) by ELISA | Anti-PD [Month 3] | 3431.8 EL.U/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Protein D (PD) by ELISA | Anti-PD [Month 9] | 4576.5 EL.U/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Protein D (PD) by ELISA | Anti-PD [Month 9] | 930.4 EL.U/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Protein D (PD) by ELISA | Anti-PD [Month 3] | 4253.1 EL.U/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Protein D (PD) by ELISA | Anti-PD [Month 3] | 2240.0 EL.U/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Protein D (PD) by ELISA | Anti-PD [Month 9] | 3141.0 EL.U/mL |
Secondary
Concentrations of Antibodies Against Protein D (PD) by ELISA.
Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay was 100 EL.U/mL. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.
Time frame: up to study end at Month 23 (24-27 months of age)
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Protein D (PD) by ELISA. | 748.3 EL.U/mL |
| HIV+/- Group | Concentrations of Antibodies Against Protein D (PD) by ELISA. | 615.3 EL.U/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Protein D (PD) by ELISA. | 503.2 EL.U/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Protein D (PD) by ELISA. | 421.3 EL.U/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Protein D (PD) by ELISA. | 323.0 EL.U/mL |
Secondary
Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status.
Concentrations of antibodies are presented as GMCs expressed as units per millilitre (U/mL). The cut-off of the assay is 20 U/mL. Data were collected for subjects who received 1, 2 doses or no Rotarix dose during the study.
Time frame: 1 month after the administration of the second vaccine dose (at Month 3)
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [2 doses] | 52.6 U/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [1 dose] | NA U/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [0 dose] | 54.8 U/mL |
| HIV+/- Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [1 dose] | NA U/mL |
| HIV+/- Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [0 dose] | 54.0 U/mL |
| HIV+/- Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [2 doses] | 104.1 U/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [1 dose] | 25.0 U/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [2 doses] | 146.4 U/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [0 dose] | 63.1 U/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [0 dose] | 47.5 U/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [1 dose] | NA U/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [2 doses] | 92.0 U/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [2 doses] | 74.3 U/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [1 dose] | NA U/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status. | Anti-rotavirus IgA [0 dose] | 41.7 U/mL |
Secondary
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups, post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. The cut-off of the assay is 0.05 µg/mL.
Time frame: At Month 3 and Month 9
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F [Month 3] | 4.95 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 [Month 3] | 7.25 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F [Month 9] | 9.92 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 [Month 3] | 3.67 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V [Month 9] | 10.09 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V [Month 3] | 4.53 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 [Month 3] | 4.00 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F [Month 3] | 1.71 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 [Month 9] | 6.97 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F [Month 9] | 8.00 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 [Month 3] | 4.99 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 [Month 9] | 6.64 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F [Month 3] | 5.70 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 [Month 9] | 7.86 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C [Month 9] | 20.26 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B [Month 3] | 1.00 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C [Month 3] | 9.55 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B [Month 9] | 2.26 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F [Month 9] | 4.00 µg/ml |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 [Month 9] | 11.50 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 [Month 3] | 6.77 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F [Month 3] | 3.69 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F [Month 3] | 1.52 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 [Month 3] | 4.79 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V [Month 9] | 10.89 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B [Month 3] | 0.94 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F [Month 9] | 11.04 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 [Month 3] | 3.85 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C [Month 9] | 19.67 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V [Month 3] | 4.25 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B [Month 9] | 2.56 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 [Month 3] | 3.14 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 [Month 9] | 9.48 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 [Month 9] | 8.64 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F [Month 9] | 12.46 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 [Month 9] | 10.58 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 [Month 9] | 8.04 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F [Month 9] | 5.90 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C [Month 3] | 9.48 µg/ml |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F [Month 3] | 11.15 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F [Month 9] | 8.88 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 [Month 3] | 3.36 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 [Month 9] | 5.38 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 [Month 3] | 2.71 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 [Month 9] | 6.07 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 [Month 3] | 4.41 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 [Month 9] | 8.05 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B [Month 3] | 0.65 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B [Month 9] | 2.05 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F [Month 3] | 3.62 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F [Month 9] | 8.98 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V [Month 3] | 3.04 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V [Month 9] | 9.55 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 [Month 3] | 3.85 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 [Month 9] | 7.33 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C [Month 3] | 10.08 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C [Month 9] | 25.47 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F [Month 3] | 8.75 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F [Month 3] | 0.92 µg/ml |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F [Month 9] | 3.83 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F [Month 3] | 4.77 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F [Month 3] | 1.59 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 [Month 3] | 5.27 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B [Month 9] | 0.93 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 [Month 9] | 2.60 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B [Month 3] | 1.06 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 [Month 9] | 0.72 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C [Month 3] | 13.20 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 [Month 9] | 1.44 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 [Month 3] | 4.65 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C [Month 9] | 3.30 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 [Month 3] | 5.71 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F [Month 3] | 10.93 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 [Month 9] | 1.07 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F [Month 9] | 2.60 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 [Month 3] | 3.77 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V [Month 3] | 5.13 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F [Month 9] | 1.78 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F [Month 9] | 0.92 µg/ml |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V [Month 9] | 1.96 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F [Month 9] | 6.47 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B [Month 9] | 1.98 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 [Month 9] | 4.92 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F [Month 9] | 3.40 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 [Month 3] | 2.51 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 [Month 9] | 5.14 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B [Month 3] | 0.57 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F [Month 3] | 0.97 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F [Month 3] | 6.90 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 [Month 9] | 5.08 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F [Month 3] | 2.72 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 [Month 9] | 6.96 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 [Month 3] | 2.28 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 [Month 3] | 3.33 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C [Month 3] | 8.65 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V [Month 3] | 2.05 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 [Month 3] | 3.45 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F [Month 9] | 9.47 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V [Month 9] | 6.51 µg/ml |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C [Month 9] | 32.29 µg/ml |
Secondary
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. The cut-off of the assay is 0.05 µg/mL.
Time frame: up to study end at Month 23 (24-27 months of age)
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 | 0.79 µg/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F | 0.73 µg/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B | 0.67 µg/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F | 2.01 µg/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C | 2.02 µg/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 | 0.56 µg/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 | 0.53 µg/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 | 2.62 µg/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V | 1.15 µg/mL |
| HIV+/+ Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F | 1.25 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 | 0.57 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 | 0.74 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 | 0.77 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B | 0.73 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F | 1.16 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V | 1.30 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 | 2.09 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C | 1.60 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F | 2.28 µg/mL |
| HIV+/- Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F | 0.85 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F | 1.08 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F | 2.53 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V | 1.05 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 | 0.72 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B | 0.60 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 | 0.44 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F | 0.51 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 | 1.32 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 | 0.42 µg/mL |
| HIV- (3+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C | 1.93 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 | 0.33 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F | 0.53 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F | 1.59 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 | 0.45 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 | 0.28 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 | 1.24 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V | 0.85 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C | 0.80 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B | 0.76 µg/mL |
| HIV- (3+0) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F | 0.67 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-6B | 0.57 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-7F | 0.84 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-18C | 2.44 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-9V | 0.80 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-14 | 1.06 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-1 | 0.33 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-23F | 0.52 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-5 | 0.52 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-19F | 2.22 µg/mL |
| HIV- (2+1) Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. | Anti-4 | 0.34 µg/mL |
Secondary
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Acquisition of new H. influenza\* (HI) and S. pneumonia(SP) strains, identified in the nasopharynx at each swab time point: Month (Mth) 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age). \*Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by PCR assay
Time frame: up to study end at Month 23 (24-27 months of age)
Population: The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV+/+ Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 8 | 34 Participants |
| HIV+/+ Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 14 | 56 Participants |
| HIV+/+ Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 11 | 69 Participants |
| HIV+/+ Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 8 | 59 Participants |
| HIV+/+ Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 23 | 72 Participants |
| HIV+/+ Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 11 | 55 Participants |
| HIV+/+ Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 14 | 68 Participants |
| HIV+/+ Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 15 | 59 Participants |
| HIV+/+ Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 9 | 64 Participants |
| HIV+/+ Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 3 | 26 Participants |
| HIV+/+ Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 9 | 45 Participants |
| HIV+/+ Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 15 | 72 Participants |
| HIV+/+ Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 3 | 35 Participants |
| HIV+/+ Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 23 | 60 Participants |
| HIV+/- Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 14 | 60 Participants |
| HIV+/- Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 23 | 87 Participants |
| HIV+/- Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 3 | 25 Participants |
| HIV+/- Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 8 | 68 Participants |
| HIV+/- Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 3 | 47 Participants |
| HIV+/- Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 15 | 67 Participants |
| HIV+/- Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 9 | 76 Participants |
| HIV+/- Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 8 | 49 Participants |
| HIV+/- Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 11 | 79 Participants |
| HIV+/- Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 11 | 67 Participants |
| HIV+/- Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 14 | 82 Participants |
| HIV+/- Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 23 | 70 Participants |
| HIV+/- Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 9 | 63 Participants |
| HIV+/- Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 15 | 86 Participants |
| HIV- (3+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 8 | 70 Participants |
| HIV- (3+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 3 | 46 Participants |
| HIV- (3+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 11 | 84 Participants |
| HIV- (3+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 9 | 77 Participants |
| HIV- (3+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 14 | 90 Participants |
| HIV- (3+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 15 | 90 Participants |
| HIV- (3+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 23 | 95 Participants |
| HIV- (3+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 3 | 27 Participants |
| HIV- (3+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 8 | 48 Participants |
| HIV- (3+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 9 | 52 Participants |
| HIV- (3+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 11 | 60 Participants |
| HIV- (3+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 14 | 58 Participants |
| HIV- (3+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 15 | 64 Participants |
| HIV- (3+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 23 | 71 Participants |
| HIV- (3+0) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 15 | 92 Participants |
| HIV- (3+0) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 8 | 42 Participants |
| HIV- (3+0) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 14 | 90 Participants |
| HIV- (3+0) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 9 | 52 Participants |
| HIV- (3+0) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 11 | 84 Participants |
| HIV- (3+0) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 3 | 41 Participants |
| HIV- (3+0) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 11 | 57 Participants |
| HIV- (3+0) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 9 | 78 Participants |
| HIV- (3+0) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 14 | 54 Participants |
| HIV- (3+0) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 8 | 67 Participants |
| HIV- (3+0) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 23 | 59 Participants |
| HIV- (3+0) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 23 | 90 Participants |
| HIV- (3+0) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 15 | 58 Participants |
| HIV- (3+0) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 3 | 29 Participants |
| HIV- (2+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 23 | 96 Participants |
| HIV- (2+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 23 | 71 Participants |
| HIV- (2+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 8 | 45 Participants |
| HIV- (2+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 14 | 93 Participants |
| HIV- (2+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 3 | 30 Participants |
| HIV- (2+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 3 | 56 Participants |
| HIV- (2+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 14 | 59 Participants |
| HIV- (2+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 9 | 57 Participants |
| HIV- (2+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 11 | 90 Participants |
| HIV- (2+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 8 | 76 Participants |
| HIV- (2+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 15 | 94 Participants |
| HIV- (2+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 15 | 65 Participants |
| HIV- (2+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any HI - Mth 11 | 65 Participants |
| HIV- (2+1) Group | Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs | Any SP - Mth 9 | 82 Participants |
Secondary
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.
Time frame: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Population: The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV+/+ Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any pain | 40 Participants |
| HIV+/+ Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 pain | 2 Participants |
| HIV+/+ Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any redness | 25 Participants |
| HIV+/+ Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Redness > 30 mm | 5 Participants |
| HIV+/+ Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any swelling | 28 Participants |
| HIV+/+ Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Swelling > 30 mm | 5 Participants |
| HIV+/- Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Swelling > 30 mm | 4 Participants |
| HIV+/- Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Redness > 30 mm | 1 Participants |
| HIV+/- Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any pain | 58 Participants |
| HIV+/- Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any redness | 31 Participants |
| HIV+/- Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 pain | 1 Participants |
| HIV+/- Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any swelling | 39 Participants |
| HIV- (3+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 pain | 2 Participants |
| HIV- (3+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any redness | 39 Participants |
| HIV- (3+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Redness > 30 mm | 3 Participants |
| HIV- (3+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Swelling > 30 mm | 8 Participants |
| HIV- (3+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any swelling | 38 Participants |
| HIV- (3+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any pain | 62 Participants |
| HIV- (2+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any swelling | 53 Participants |
| HIV- (2+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Swelling > 30 mm | 10 Participants |
| HIV- (2+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 pain | 6 Participants |
| HIV- (2+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Redness > 30 mm | 0 Participants |
| HIV- (2+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any pain | 60 Participants |
| HIV- (2+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any redness | 45 Participants |
Secondary
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.
Time frame: During the 4-day (Days 0-3) post-primary vaccination period across doses
Population: The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV+/+ Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any pain | 73 Participants |
| HIV+/+ Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 pain | 18 Participants |
| HIV+/+ Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any redness | 62 Participants |
| HIV+/+ Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Redness > 30 mm | 14 Participants |
| HIV+/+ Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any swelling | 67 Participants |
| HIV+/+ Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Swelling > 30 mm | 23 Participants |
| HIV+/- Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any swelling | 83 Participants |
| HIV+/- Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Swelling > 30 mm | 32 Participants |
| HIV+/- Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any pain | 93 Participants |
| HIV+/- Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any redness | 80 Participants |
| HIV+/- Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Redness > 30 mm | 10 Participants |
| HIV+/- Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 pain | 18 Participants |
| HIV- (3+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Redness > 30 mm | 17 Participants |
| HIV- (3+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any swelling | 84 Participants |
| HIV- (3+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any pain | 92 Participants |
| HIV- (3+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any redness | 83 Participants |
| HIV- (3+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 pain | 28 Participants |
| HIV- (3+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Swelling > 30 mm | 41 Participants |
| HIV- (3+0) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Redness > 30 mm | 20 Participants |
| HIV- (3+0) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 pain | 42 Participants |
| HIV- (3+0) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any redness | 83 Participants |
| HIV- (3+0) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Swelling > 30 mm | 44 Participants |
| HIV- (3+0) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any swelling | 91 Participants |
| HIV- (3+0) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any pain | 95 Participants |
| HIV- (2+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any swelling | 84 Participants |
| HIV- (2+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any redness | 84 Participants |
| HIV- (2+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Grade 3 pain | 34 Participants |
| HIV- (2+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Swelling > 30 mm | 31 Participants |
| HIV- (2+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Redness > 30 mm | 14 Participants |
| HIV- (2+1) Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). | Any pain | 97 Participants |
Secondary
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Population: The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any loss of appetite | 17 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related loss of appetite | 16 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 irritability | 4 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any drowsiness | 17 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related irritability | 24 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related drowsiness | 16 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever >= 37.5°C | 9 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 drowsiness | 2 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 loss of appetite | 0 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever > 39.5°C | 0 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related fever | 8 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any irritability | 25 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 drowsiness | 0 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any irritability | 35 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever >= 37.5°C | 11 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related irritability | 35 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any loss of appetite | 23 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 irritability | 1 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any drowsiness | 28 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related fever | 10 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever > 39.5°C | 0 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related drowsiness | 27 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related loss of appetite | 23 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 loss of appetite | 0 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 irritability | 1 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any drowsiness | 34 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 drowsiness | 1 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related drowsiness | 31 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever >= 37.5°C | 7 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever > 39.5°C | 0 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related fever | 7 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any irritability | 31 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related irritability | 31 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any loss of appetite | 29 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 loss of appetite | 1 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related loss of appetite | 29 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related fever | 10 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever > 39.5°C | 0 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any drowsiness | 33 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any loss of appetite | 37 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever >= 37.5°C | 11 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related drowsiness | 32 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related loss of appetite | 33 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 loss of appetite | 2 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 irritability | 1 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any irritability | 43 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 drowsiness | 1 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related irritability | 42 Participants |
Secondary
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
General AEs = diarrhoea, drowsiness, irritability, loss of appetite, vomiting and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. diarrhoea: ≥ 6 looser than normal stools/day. vomiting: ≥ 3 episodes of vomiting/day. Fever = \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Days 0-3) post-primary vaccination period across doses
Population: The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever (axillary) > 39.5°C | 0 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever (axillary) >= 37.5°C | 38 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 drowsiness | 1 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any vomiting | 17 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related drowsiness | 47 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 diarrhoea | 2 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related vomiting | 16 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related loss of appetite | 35 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 loss of appetite | 0 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any loss of appetite | 36 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related diarrhoea | 8 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any diarrhoea | 8 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related irritability | 62 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 irritability | 6 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any irritability | 63 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any drowsiness | 49 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 vomiting | 3 Participants |
| HIV+/+ Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related fever | 33 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related diarrhoea | 5 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any diarrhoea | 5 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 diarrhoea | 0 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any drowsiness | 62 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 drowsiness | 6 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related drowsiness | 58 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever (axillary) >= 37.5°C | 36 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever (axillary) > 39.5°C | 0 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related fever | 30 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any irritability | 84 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 irritability | 10 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related irritability | 80 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any loss of appetite | 53 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 loss of appetite | 1 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related loss of appetite | 47 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any vomiting | 19 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 vomiting | 3 Participants |
| HIV+/- Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related vomiting | 16 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related vomiting | 14 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related diarrhoea | 11 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related drowsiness | 67 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related irritability | 86 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any vomiting | 15 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related loss of appetite | 53 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 diarrhoea | 3 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 loss of appetite | 2 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any loss of appetite | 56 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any drowsiness | 70 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any diarrhoea | 12 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any irritability | 89 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever (axillary) > 39.5°C | 2 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 drowsiness | 5 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related fever | 38 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 vomiting | 4 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 irritability | 19 Participants |
| HIV- (3+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever (axillary) >= 37.5°C | 41 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 drowsiness | 7 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever (axillary) > 39.5°C | 0 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any diarrhoea | 10 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related fever | 27 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related vomiting | 13 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any irritability | 89 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related diarrhoea | 9 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 irritability | 13 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 vomiting | 5 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related irritability | 83 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any loss of appetite | 57 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 diarrhoea | 3 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 loss of appetite | 2 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related loss of appetite | 53 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related drowsiness | 66 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any vomiting | 18 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever (axillary) >= 37.5°C | 28 Participants |
| HIV- (3+0) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any drowsiness | 70 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related irritability | 85 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever (axillary) >= 37.5°C | 28 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related loss of appetite | 58 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any diarrhoea | 5 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 irritability | 15 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any vomiting | 23 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 drowsiness | 8 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any irritability | 91 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related diarrhoea | 5 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related fever | 25 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Fever (axillary) > 39.5°C | 0 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related drowsiness | 63 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any loss of appetite | 62 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 vomiting | 2 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Any drowsiness | 68 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 loss of appetite | 5 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Grade 3 diarrhoea | 2 Participants |
| HIV- (2+1) Group | Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs). | Related vomiting | 17 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: From study start at Month 0 (6 weeks of age and above) up to study end at Month 23 (24-27 months of age)
Population: The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV+/+ Group | Number of Subjects With Serious Adverse Events (SAEs). | 31 Participants |
| HIV+/- Group | Number of Subjects With Serious Adverse Events (SAEs). | 25 Participants |
| HIV- (3+1) Group | Number of Subjects With Serious Adverse Events (SAEs). | 20 Participants |
| HIV- (3+0) Group | Number of Subjects With Serious Adverse Events (SAEs). | 15 Participants |
| HIV- (2+1) Group | Number of Subjects With Serious Adverse Events (SAEs). | 20 Participants |
Secondary
Number of Subjects With Unsolicited AEs.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Population: The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV+/+ Group | Number of Subjects With Unsolicited AEs. | 35 Participants |
| HIV+/- Group | Number of Subjects With Unsolicited AEs. | 47 Participants |
| HIV- (3+1) Group | Number of Subjects With Unsolicited AEs. | 50 Participants |
| HIV- (2+1) Group | Number of Subjects With Unsolicited AEs. | 44 Participants |
Secondary
Number of Subjects With Unsolicited AEs.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within the 31-day (Days 0-30) post-primary vaccination period
Population: The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV+/+ Group | Number of Subjects With Unsolicited AEs. | 73 Participants |
| HIV+/- Group | Number of Subjects With Unsolicited AEs. | 92 Participants |
| HIV- (3+1) Group | Number of Subjects With Unsolicited AEs. | 93 Participants |
| HIV- (3+0) Group | Number of Subjects With Unsolicited AEs. | 90 Participants |
| HIV- (2+1) Group | Number of Subjects With Unsolicited AEs. | 97 Participants |
Secondary
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Positive cultures of H. influenza\* (HI) and S. pneumonia(SP) and other bacterial pathogens such as Moraxella catarrhalis(MC), Group A streptococci and Staphylococcus aureus (SA), identified in the nasopharynx at each swab time point: Month (Mth) 0 (Pre-vaccination time point at 6-12 weeks of age), Mth 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age). \*Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay
Time frame: up to study end at Month 23 (24-27 months of age)
Population: The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 0 | 14 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 3 | 47 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 8 | 55 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 9 | 50 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 11 | 52 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 14 | 52 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 15 | 59 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 23 | 58 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 0 | 23 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 3 | 30 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 8 | 21 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 9 | 28 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 11 | 33 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 14 | 29 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 15 | 35 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 23 | 39 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 0 | 35 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 3 | 63 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 8 | 56 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 9 | 62 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 11 | 69 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 14 | 65 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 15 | 60 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 23 | 59 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 0 | 37 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 3 | 41 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 11 | 9 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 8 | 16 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 9 | 19 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 14 | 11 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 15 | 12 Swabs |
| HIV+/+ Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 23 | 8 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 8 | 83 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 9 | 26 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 14 | 39 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 8 | 18 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 14 | 15 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 3 | 88 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 0 | 12 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 15 | 54 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 14 | 64 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 0 | 39 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 23 | 45 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 8 | 61 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 3 | 62 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 11 | 61 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 3 | 34 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 23 | 59 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 0 | 24 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 3 | 37 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 0 | 48 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 8 | 41 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 15 | 68 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 23 | 73 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 15 | 11 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 15 | 82 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 9 | 47 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 9 | 64 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 14 | 81 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 11 | 80 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 23 | 16 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 11 | 44 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 11 | 18 Swabs |
| HIV+/- Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 9 | 79 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 15 | 83 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 23 | 63 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 0 | 17 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 8 | 13 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 3 | 36 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 8 | 34 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 9 | 34 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 11 | 36 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 14 | 38 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 9 | 18 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 15 | 54 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 23 | 58 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 0 | 42 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 23 | 10 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 3 | 88 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 8 | 84 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 14 | 9 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 9 | 75 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 11 | 73 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 14 | 84 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 15 | 62 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 23 | 78 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 15 | 20 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 0 | 56 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 3 | 37 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 0 | 25 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 3 | 58 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 8 | 65 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 9 | 62 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 11 | 13 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 11 | 67 Swabs |
| HIV- (3+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 14 | 69 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 3 | 40 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 3 | 33 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 11 | 13 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 0 | 30 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 15 | 87 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 14 | 13 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 9 | 29 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 8 | 30 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 3 | 55 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 9 | 81 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 23 | 71 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 9 | 16 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 14 | 90 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 0 | 12 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 23 | 53 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 9 | 66 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 8 | 19 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 15 | 51 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 15 | 70 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 0 | 42 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 11 | 62 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 8 | 67 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 0 | 57 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 11 | 34 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 3 | 87 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 23 | 13 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 14 | 31 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 15 | 13 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 11 | 73 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 8 | 79 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 14 | 70 Swabs |
| HIV- (3+0) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 23 | 60 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 8 | 67 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 9 | 72 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 9 | 32 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 11 | 83 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 14 | 13 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 9 | 70 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 14 | 84 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 8 | 24 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 14 | 70 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 15 | 86 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 8 | 38 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 23 | 18 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 23 | 79 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 11 | 19 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 0 | 55 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 3 | 37 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 11 | 70 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 0 | 17 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 3 | 32 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 0 | 12 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 15 | 68 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 3 | 64 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 15 | 18 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 15 | 55 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 23 | 62 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SA - Mth 9 | 17 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 0 | 44 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 14 | 27 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 3 | 90 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any HI - Mth 11 | 40 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any SP - Mth 23 | 66 Swabs |
| HIV- (2+1) Group | Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx. | Any MC - Mth 8 | 82 Swabs |
Secondary
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.
Time frame: up to study end at Month 23 (24-27 months of age)
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIV+/+ Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono-6A | 14.2 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono-19A | 19.9 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono-6A | 15.7 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono-19A | 15.8 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono-6A | 20.5 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono-19A | 25.1 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono-19A | 14.5 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono-6A | 15.3 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono-6A | 19.0 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono-19A | 16.8 Titers |
Secondary
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.
Time frame: At Month 3 and at Month 9
Population: ATP cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIV+/+ Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -19A [Month 3] | 9.5 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -6A [Month 9] | 26.4 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -6A [Month 3] | 7.7 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -19A [Month 9] | 42.0 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -19A [Month 9] | 101.8 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -19A [Month 3] | 15.2 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -6A [Month 9] | 38.6 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -6A [Month 3] | 11.5 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -19A [Month 3] | 10.6 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -6A [Month 9] | 40.4 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -6A [Month 3] | 12.1 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -19A [Month 9] | 38.3 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -19A [Month 3] | 14.2 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -19A [Month 9] | 7.9 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -6A [Month 9] | 9.5 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -6A [Month 3] | 13.8 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -6A [Month 3] | 8.1 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -19A [Month 3] | 7.8 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -6A [Month 9] | 42.2 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. | Opsono -19A [Month 9] | 36.1 Titers |
Secondary
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.
Time frame: up to study end at Month 23 (24-27 months of age)
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 | 22.5 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F | 97.6 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B | 100.0 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F | 41.8 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C | 21.1 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 | 76.6 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 | 36.7 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 | 452.0 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V | 507.6 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F | 6367.5 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 | 141.7 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 | 28.1 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 | 19.1 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B | 75.5 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F | 7396.6 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V | 598.6 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 | 472.8 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C | 26.7 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F | 73.2 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F | 154.8 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V | 1060.7 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F | 52.5 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 | 19.5 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B | 116.6 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 | 125.5 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F | 6365.0 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 | 362.3 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 | 22.8 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F | 69.7 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C | 48.7 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 | 21.6 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F | 92.7 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 | 12.3 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 | 8.6 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V | 412.3 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C | 9.8 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F | 28.2 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 | 361.5 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B | 87.2 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F | 5601.1 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B | 55.9 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F | 47.6 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F | 5859.9 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V | 465.7 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F | 103.5 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 | 185.2 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 | 13.9 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C | 41.6 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 | 13.3 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 | 58.8 Titers |
Secondary
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.
Time frame: At Month 3 and at Month 9
Population: The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F [Month 3] | 4025.2 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F [Month 3] | 338.0 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 [Month 3] | 2656.2 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F [Month 9] | 10656.1 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 [Month 3] | 671.6 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V [Month 9] | 2436.8 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V [Month 3] | 1197.2 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 [Month 3] | 139.7 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 [Month 9] | 2034.2 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F [Month 9] | 1327.4 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F [Month 9] | 488.2 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 [Month 3] | 105.7 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 [Month 9] | 1061.5 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F [Month 3] | 228.6 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 [Month 9] | 540.4 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C [Month 9] | 1039.3 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B [Month 3] | 239.7 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C [Month 3] | 438.7 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B [Month 9] | 853.0 Titers |
| HIV+/+ Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 [Month 9] | 2205.9 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B [Month 3] | 480.5 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F [Month 3] | 10158.3 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 [Month 3] | 128.6 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 [Month 3] | 147.6 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V [Month 9] | 3215.4 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F [Month 3] | 769.6 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F [Month 9] | 18816.6 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C [Month 9] | 1036.5 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 [Month 9] | 2374.3 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V [Month 3] | 1736.5 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 [Month 9] | 531.1 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 [Month 3] | 1518.1 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F [Month 9] | 2120.7 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 [Month 9] | 1377.8 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F [Month 9] | 1357.5 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 [Month 3] | 3175.1 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 [Month 9] | 3259.0 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C [Month 3] | 575.9 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B [Month 9] | 986.6 Titers |
| HIV+/- Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F [Month 3] | 590.3 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F [Month 9] | 730.8 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 [Month 3] | 127.2 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 [Month 9] | 1014.8 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 [Month 3] | 1711.9 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 [Month 9] | 2484.7 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 [Month 3] | 107.4 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 [Month 9] | 630.2 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B [Month 3] | 499.5 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B [Month 9] | 1047.2 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F [Month 3] | 5910.5 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F [Month 9] | 12108.8 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V [Month 3] | 1672.2 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V [Month 9] | 4250.1 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 [Month 3] | 1902.7 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 [Month 9] | 2180.0 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C [Month 3] | 1046.9 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C [Month 9] | 1344.4 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F [Month 3] | 511.9 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F [Month 3] | 864.1 Titers |
| HIV- (3+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F [Month 9] | 2144.8 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F [Month 3] | 6834.5 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F [Month 3] | 1107.0 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 [Month 3] | 2205.0 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B [Month 9] | 261.5 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 [Month 9] | 280.0 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B [Month 3] | 1213.7 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C [Month 3] | 1203.2 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 [Month 9] | 30.5 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 [Month 3] | 268.7 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C [Month 9] | 64.5 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 [Month 3] | 189.2 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F [Month 3] | 649.3 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 [Month 9] | 112.3 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 [Month 3] | 1890.6 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F [Month 9] | 46.8 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 [Month 9] | 23.5 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V [Month 3] | 2216.0 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F [Month 9] | 2741.1 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F [Month 9] | 83.6 Titers |
| HIV- (3+0) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V [Month 9] | 492.3 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 [Month 9] | 1003.6 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B [Month 9] | 945.9 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 [Month 9] | 1717.6 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F [Month 9] | 1557.2 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 [Month 3] | 380.9 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F [Month 9] | 6029.3 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-6B [Month 3] | 361.2 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-23F [Month 3] | 509.6 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F [Month 3] | 275.9 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-14 [Month 9] | 1152.9 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V [Month 9] | 2572.5 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 [Month 9] | 472.7 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-1 [Month 3] | 160.6 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-4 [Month 3] | 774.8 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C [Month 3] | 1052.3 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-7F [Month 3] | 2650.0 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-5 [Month 3] | 105.7 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-9V [Month 3] | 1068.2 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-19F [Month 9] | 630.3 Titers |
| HIV- (2+1) Group | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. | Opsono-18C [Month 9] | 1441.3 Titers |