Synflorix

Manufactured by GlaxoSmithKline

Sourced in Belgium

Synflorix is a pneumococcal polysaccharide conjugate vaccine developed by GlaxoSmithKline. It is designed to prevent invasive pneumococcal disease and pneumonia caused by Streptococcus pneumoniae in infants and children.

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Lab products found in correlation

Prevenar13, by Pfizer (5 mentions) Pediacel, by Sanofi (1 mentions) Pneumovax, by Merck Group (1 mentions) Infanrix hexa, by GlaxoSmithKline (1 mentions) Prevnar, by Pfizer (1 mentions) Prevnar13, by Pfizer (1 mentions) Pneumovax 23, by Merck Group (1 mentions) Rotarix, by GlaxoSmithKline (1 mentions)

11 protocols using synflorix

Ibuprofen for Vaccine-Related Pain

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The vaccines administered were: diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed combined with inactivated poliomyelitis vaccine and Haemophilus b conjugate vaccine (Pediacel ® ; Sanofi-Pasteur) and the pneumococcal conjugate 10-valent vaccines (Synflorix ® ; GlaxoSmithKline). The two vaccines were administered intramuscularly in the anterolateral region of each thigh, 60 minutes after topical EMLA ® cream (0.5 g in a thick layer).
On enrollment, patients were randomized into two groups: the study group received oral ibuprofen (Advil ® Pediatric drops; Wyeth-Ayerst) 5 mg/kg/dose (Ibuprofen; n=28) and the control group received an oral placebo (Placebo; n=28) prepared by the CHU Sainte-Justine pharmacy. Patients were randomly assigned into the two groups using 40 blocks of 4 with a computer generated-randomization list extracted from the website randomization.com. The randomization was done by the central hospital pharmacy to keep the investigators blinded.
The drugs were administered in an opaque syringe 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses (Figure 1).

Ben Jmaa W., Hernández A.I., Sutherland M.R., Cloutier A., Germain N., Lachance C., Martin B., Lebel M.H., Pladys P, & Nuyt A.M. (2017). Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants < 32 Weeks Gestational Age: A Randomized Controlled Study. The Pediatric infectious disease journal, 36(10).

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Pneumococcal Vaccination Impact on Pediatric Burden

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A previously published Markov model³¹ (link) was adapted to simulate the impact of neonatal pneumococcal vaccination on epidemiological and economic burden of meningitis, bacteremia, pneumonia, and AOM, within a cohort of newborns in Italy.
Local data were used to populate the model wherever available, and all the assumptions and data sources were based on an in-depth evidence review. The analysis was conducted from the Italian National Health Service (NHS) perspective and compares 2 + 1 regimes of PHiD-CV (Synflorix, GSK) and PCV-13 (Prevenar 13, Pfizer) (doses administered at 3, 5, and 11 months) vs. PCV-7 (equaled to a strategy able to maintain current epidemiology) and no vaccination (in which a rebound to pre-PCV epidemiology is expected).
Given the uncertainty associated with epidemiological evolution and future available strategies, the usual lifetime horizon was considered to be too long and barely relevant. The time horizon was limited to the whole pediatric age (up to 18 years) for the base-case and to pre-scholar age (up to 5 years, the follow-up time of the clinical studies from which inputs were obtained) as scenario analysis.

Castiglia P., Pradelli L., Castagna S., Freguglia V., Palù G, & Esposito S. (2017). Overall effectiveness of pneumococcal conjugate vaccines: An economic analysis of PHiD-CV and PCV-13 in the immunization of infants in Italy. Human Vaccines & Immunotherapeutics, 13(10), 2307-2315.

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Pneumococcal Vaccine Composition and Dosage

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A single dose (0.5 mL) of 10vPCV (Synflorix®, GSK, Belgium, batches ASPNA0099AB, ASPNA267DD) contains 1 μg of each pneumococcal polysaccharide for serotypes 1, 5, 6B, 7F, 9 V, 14 and 23F and 3 μg of serotype 4, each conjugated to Protein D of NTHi and 3 μg of serotypes 18C and 19F conjugated to tetanus and diphtheria toxoids, respectively. One dose (0.5 ml) of 13vPCV (Prevenar 13®, Pfizer, USA, batch numbers F36226, G71540) contains 2.2 μg of pneumococcal purified capsular polysaccharides for serotypes 1, 3, 4, 5, 6A, 7F, 9 V, 14, 18C, 19A, 19F and 23F, and 4.4 μg of pneumococcal purified capsular polysaccharides for serotype 6B and 0.125 mg aluminium adjuvant. Each serotype is individually conjugated to non-toxic diphtheria CRM₁₉₇ protein.
Each 0.5 mL dose of PPV (Pneumovax®23 Merck & Co, USA, batch numbers T0861, V1200, K006913) contains 25 μg of purified capsular polysaccharides of each of serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9 N, 9 V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F and 0.25% phenol preservative.

Lehmann D., Kirarock W., van den Biggelaar A.H., Passey M., Jacoby P., Saleu G., Masiria G., Nivio B., Greenhill A., Orami T., Francis J., Ford R., Kirkham L.A., Solomon V., Richmond P.C, & Pomat W.S. (2017). Rationale and methods of a randomized controlled trial of immunogenicity, safety and impact on carriage of pneumococcal conjugate and polysaccharide vaccines in infants in Papua New Guinea. Pneumonia, 9, 20.

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PCV10 Pneumococcal Conjugate Vaccine Composition

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The PCV10 vaccine (Synflorix, GSK, Brentford, England) is a formulation of pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine; a decavalent (10-antigen containing) vaccine composed of partially hydrolyzed capsular (outer coat) polysaccharide and oligosaccharide antigens from 10 Streptococcus pneumoniae bacteria serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F). 11 Eight of the antigens are chemically conjugated to H. influenzae protein D from a nontypeable strain of H. influenzae, 1 conjugated to a Diphtheria toxoid carrier protein and another conjugated to a Clostridium tetani (tetanus) toxoid carrier protein. 11

Crawford N.W., Balloch A., Tikkanen L., Merchinaud F., Downie P, & Buttery J.P. (2015). Pneumococcal conjugate vaccine administration during therapy for pediatric leukemia. The Pediatric infectious disease journal, 34(1).

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Comparing PCV10 and PCV13 Vaccinations

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Children in the PCV10 group were vaccinated with Synflorix (GSK, Belgium) during regular visits to well-baby clinics. PCV10 contains 1 μg of serotypes 1, 5, 6B, 7F, 9V, 14, and 23F and 3 μg of serotypes 4, 18C, and 19F. The polysaccharides are conjugated to protein D, except for 18C (tetanus toxoid) and 19F (diphtheria toxoid). Children in the PCV13 group received Prevenar13 (Pfizer, UK) during home visits by the study team. This vaccine contains 2.2 μg of serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, all conjugated to diphtheria toxoid CRM₁₉₇. Both groups concomitantly received Infanrix-hexa (GSK, Belgium) against diphtheria, tetanus, acellular pertussis, hepatitis B, poliovirus, and Haemophilus influenzae type B (conjugated to tetanus toxoid), at 2, 3, 4, and 11 months of age.

van Westen E., Wijmenga-Monsuur A.J., van Dijken H.H., van Gaans-van den Brink J.A., Kuipers B., Knol M.J., Berbers G.A., Sanders E.A., Rots N.Y, & van Els C.A. (2015). Differential B-Cell Memory Around the 11-Month Booster in Children Vaccinated With a 10- or 13-Valent Pneumococcal Conjugate Vaccine. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, 61(3), 342-349.

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Pentavalent and Hexavalent Vaccine Comparison

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Pentavalent vaccine (DTwP-HBV-Hib; Eupenta, LG Chem; Seoul, South Korea) and hexavalent vaccine (DTaP-IPV-HBV-Hib; Infanrix-Hexa, GlaxoSmithKline, Mississauga, Canada) were used in this study. According to the group assigned, the participants received 0.5 ml of the vaccines intramuscularly at 2, 4 and 6 months of age. The components of each vaccine are listed in Table, Supplemental Digital Content 1, https://links.lww.com/INF/F600. Concomitant pneumococcal conjugated vaccination (either with Prevnar, Pfizer, Bruxelles, Belgium or Synflorix, GlaxoSmithKline; Ontario, Canada) at 2-, 4-and 6-month-old and administration of seasonal influenza vaccine were at the discretion of parents.

Soonthornarrak K., Limrungsikul A, & Apiwattanakul N. (2024). Comparison of Hepatitis B Surface Antibody Levels After Vaccination With Combined One Dose of Hexavalent Vaccine and Two Doses of Pentavalent Vaccine Versus Three Doses of Pentavalent Vaccine. The Pediatric infectious disease journal.

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Pneumococcal Vaccine Dosing Strategies

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Infants were randomly assigned (1:1:1:1:1:1) through block randomisation (block size 30) to one of the six study groups. Study numbers and the corresponding randomisation group were allocated to eligible participants in sequential order by study staff. Randomisation allocated infants to receive a single priming dose of PCV10 (Synflorix, GlaxoSmithKline, Rixensart, Belgium; which includes serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19FD and 23F) or PCV13 (Prevnar-13, Pfizer, New York City, USA; which includes all PCV10 serotypes and serotypes 3, 6A, and 19A) at 6 weeks (6w + 1 PCV10 group or 6w + 1 PCV13 group) or 14 weeks (14w + 1 PCV10 group or 14w + 1 PCV13 group) of age or two priming doses, one each at 6 and 14 weeks of age (2 + 1 PCV10 group or 2 + 1 PCV13 group). Infants in all groups received a booster dose of the corresponding PCV formulation at 40 weeks of age. Parents of participants and clinical staff were not masked to study-group assignment. Laboratory personnel were masked to the participant's identity and randomisation assignment throughout the study.

Madhi S.A., Mutsaerts E.A., Izu A., Boyce W., Bhikha S., Ikulinda B.T., Jose L., Koen A., Nana A.J., Moultrie A., Roalfe L., Hunt A., Goldblatt D., Cutland C.L, & Dorfman J.R. (2020). Immunogenicity of a single-dose compared with a two-dose primary series followed by a booster dose of ten-valent or 13-valent pneumococcal conjugate vaccine in South African children: an open-label, randomised, non-inferiority trial. The Lancet. Infectious Diseases, 20(12), 1426-1436.

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Pneumococcal Vaccine Composition and Formulations

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PCV10 (Synflorix^®, GSK, Rixensart, Belgium, batch numbers ASPNA0099AB and ASPNA267DD) contains pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14 and 23F polysaccharide conjugated to non-typeable Haemophilus influenzae Protein D, and serotypes 18C and 19F polysaccharide conjugated to tetanus and diphtheria toxoids, respectively. PCV13 (Prevenar13^®, Pfizer, New York City, NY, USA, batch numbers F36226 and G71540) contains pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F conjugated to non-toxic diphtheria CRM₁₉₇ protein. Each 0.5 mL dose of PPV (Pneumovax 23^™, Merck & Co., Kenilworth, NJ, USA, batch numbers T0861, V1200 and K006913) contains 25 µg of purified capsular polysaccharides of serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F in 0.25% phenol preservative.

van den Biggelaar A.H., Pomat W.S., Masiria G., Wana S., Nivio B., Francis J., Ford R., Passey M., Kirkham L.A., Jacoby P., Lehmann D, & Richmond P. (2019). Immunogenicity and Immune Memory after a Pneumococcal Polysaccharide Vaccine Booster in a High-Risk Population Primed with 10-Valent or 13-Valent Pneumococcal Conjugate Vaccine: A Randomized Controlled Trial in Papua New Guinean Children. Vaccines, 7(1), 17.

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Comparative Analysis of PCV10 and PCV13 Vaccines

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PCV10 (Synflorix^®, GSK, Wavre, Belgium) contains 1 μg polysaccharide (PS) for serotypes 1, 5, 6B, 7F, 9V, 14, and 23 F and 3 μg for serotypes 4, 18C, and 19F. All polysaccharides were conjugated to protein D from Haemophilus influenzae type b, with the exceptions of serotype 18C (conjugated to tetanus toxoid) and 19F (conjugated to diphtheria toxoid). PCV13 (Prevenar13^®, Pfizer, Tadworth, UK) contains the same serotypes as PCV10 with the addition of serotypes 3, 6A, and 19A, and all serotypes were conjugated to CRM₁₉₇ at a concentration of 2.2 μg PS, except for serotype 6B (4.4 μg).
Infants in trial NTR3069 concomitantly received Infanrix-hexa (DTaP-IPV-HBV-Hib) (GSK, Wavre, Belgium), directed against infections with diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and hepatitis B. Infants in trial NTR2316 concomitantly received Pediacel (DTaP-IPV-Hib, Sanofi Pasteur, Lyon, France), protecting against the same pathogens, but without hepatitis B. In study NTR3069, PCV10 was administered during routine visits to well-baby clinics, while PCV13 was given during home visits by study nurses in both studies.

van Westen E., Knol M.J., Wijmenga-Monsuur A.J., Tcherniaeva I., Schouls L.M., Sanders E.A., van Els C.A., Berbers G.A, & Rots N.Y. (2018). Serotype-Specific IgG Antibody Waning after Pneumococcal Conjugate Primary Series Vaccinations with either the 10-Valent or the 13-Valent Vaccine. Vaccines, 6(4), 82.

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PCV10 Vaccine Impact Study in Bangladesh

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The methodology for the 10‐valent pneumococcal conjugate vaccine (PCV10; Synflorix, GlaxoSmithKline) impact study in Sylhet, Bangladesh, was published previously.19 Briefly, the PCV10 impact study involved community‐ and facility‐based surveillance conducted in Sylhet, Bangladesh, between January 2014 and June 2018.19 The parent study sought to assess the impact of PCV10 against multiple endpoints including invasive pneumococcal disease, chest radiograph‐defined pneumonia, and LUS‐defined pneumonia, with multiple secondary aims including assessing the validity of LUS as a tool for pneumonia diagnosis in low‐resource settings.

Pervaiz F., Hossen S., Chavez M.A., Miele C.H., Moulton L.H., McCollum E.D., Roy A.D., Chowdhury N.H., Ahmed S., Begum N., Quaiyum A., Santosham M., Baqui A.H, & Checkley W. (2019). Training and standardization of general practitioners in the use of lung ultrasound for the diagnosis of pediatric pneumonia. Pediatric Pulmonology, 54(11), 10.1002/ppul.24477.

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